Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT04333758
Status:
COMPLETED
Last Update Posted:
2024-06-18
First Post:
2020-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Chien_Joo_LIM@ttsh.com.sg', 'phone': '9035249', 'title': 'Ms Lim Chien Joo', 'organization': 'Tan Tock Seng Hospital Pte Ltd'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Results may be affected by participants having concurrent therapy, home exercise programs or other stroke-related treatment whilst undergoing the research, as these factors are not controlled for by this study design.'}}, 'adverseEventsModule': {'timeFrame': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training.", 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fugl Meyer Upper Limb Motor Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '36.52', 'spread': '16.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fugl Meyer Upper Limb Motor Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '38.48', 'spread': '16.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 3', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fugl Meyer Upper Limb Motor Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '39.17', 'spread': '16.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Fugl Meyer Upper Limb Motor Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '40.00', 'spread': '16.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Berg Balance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '43.34', 'spread': '9.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Berg Balance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '47.17', 'spread': '8.64', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 3', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Berg Balance Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '47.59', 'spread': '9.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Berg Balance Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '48.59', 'spread': '8.97', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '206.23', 'spread': '129.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '227.67', 'spread': '144.46', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 3', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '239.83', 'spread': '148.56', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '6 Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '250.78', 'spread': '158.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '10 Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '10 Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 3', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '10 Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '0.51', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '10 Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.78', 'spread': '0.52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.', 'unitOfMeasure': 'meters/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '0.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.103', 'groupId': 'OG000', 'lowerLimit': '-0.112', 'upperLimit': '0.319'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 3', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '0.000', 'groupId': 'OG000', 'lowerLimit': '0.000', 'upperLimit': '0.000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Numerical Pain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '-0.103', 'groupId': 'OG000', 'lowerLimit': '-0.397', 'upperLimit': '0.190'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced).", 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stroke Self-Efficacy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '80.79', 'spread': '19.30', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0', 'description': 'Measures a stroke survivor\'s perceived level of confidence in functional performance.\n\nEach of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".\n\nThe points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stroke Self-Efficacy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '91.79', 'spread': '20.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 7', 'description': 'Measures a stroke survivor\'s perceived level of confidence in functional performance.\n\nEach of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".\n\nThe points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Stroke Self-Efficacy Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'classes': [{'categories': [{'measurements': [{'value': '93.59', 'spread': '20.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 11', 'description': 'Measures a stroke survivor\'s perceived level of confidence in functional performance.\n\nEach of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".\n\nThe points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome..', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Jintronix Intervention', 'description': "2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.\n\nJintronix Virtual Reality Telerehabilitation System: System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.03', 'spread': '11.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Chinese', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}, {'title': 'Malay', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Indian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Others', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Singapore', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Handedness', 'classes': [{'categories': [{'title': 'Right', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Left', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Education, Customized', 'classes': [{'categories': [{'title': 'Primary School', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Secondary School', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Institute of Technical Education', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Polytechnic Education', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Tertiary Education', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Gaming Experience: Yes, No', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Post Stroke Duration, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '320.50', 'groupId': 'BG000', 'lowerLimit': '202.75', 'upperLimit': '871.25'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'days', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Nature of Stroke: Infarct, Haemorrhage', 'classes': [{'categories': [{'title': 'Infarct', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Haemorrhage', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Side of Stroke: Left, Right, Bilateral', 'classes': [{'categories': [{'title': 'Left', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Right', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Bilateral', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}, {'title': 'Involved Side: Left, Right', 'classes': [{'categories': [{'title': 'Left', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Right', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'There are 3 drop-outs from the study.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-08-30', 'size': 852544, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-11T23:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective open label study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-28', 'studyFirstSubmitDate': '2020-03-17', 'resultsFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-04-01', 'lastUpdatePostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-05-28', 'studyFirstPostDateStruct': {'date': '2020-04-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl Meyer Upper Limb Motor Assessment', 'timeFrame': 'Week 0', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.'}, {'measure': 'Fugl Meyer Upper Limb Motor Assessment', 'timeFrame': 'Week 3', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.'}, {'measure': 'Fugl Meyer Upper Limb Motor Assessment', 'timeFrame': 'Week 7', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.'}, {'measure': 'Fugl Meyer Upper Limb Motor Assessment', 'timeFrame': 'Week 11', 'description': 'Measures motor impairment of upper limb recovery from a neurological insult. Range of scores from 0-66 points. Total score of 66 points with higher scores indicating better arm motor functions.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Week 0', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Week 3', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.'}, {'measure': 'Berg Balance Scale Score', 'timeFrame': 'Week 7', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.'}, {'measure': 'Berg Balance Scale', 'timeFrame': 'Week 11', 'description': 'Measures static and dynamic balance abilities. Range of scores from 0-56 points. Total score of 56 points with higher scores indicating better balance functions.'}, {'measure': '6 Minute Walk Test', 'timeFrame': 'Week 0', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.'}, {'measure': '6 Minute Walk Test', 'timeFrame': 'Week 3', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.'}, {'measure': '6 Minute Walk Test', 'timeFrame': 'Week 7', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.'}, {'measure': '6 Minute Walk Test', 'timeFrame': 'Week 11', 'description': 'Measures endurance inferred from distance measured directly via distance markers placed on ground, as the participant walked up and down repeatedly on a flat ground walking track for a duration of 6 minutes.\n\nHigher distance covered by participant in this 6 minutes indicates a better outcome of higher endurance. There is no lower and upper distance limits set for this measure.'}, {'measure': '10 Meter Walk Test', 'timeFrame': 'Week 0', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.'}, {'measure': '10 Meter Walk Test', 'timeFrame': 'Week 3', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.'}, {'measure': '10 Meter Walk Test', 'timeFrame': 'Week 7', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.'}, {'measure': '10 Meter Walk Test', 'timeFrame': 'Week 11', 'description': 'Measures walking speed as participant walked on a flat ground walking track of 10 metres. Walking speed is calcuated by dividing 10 metres over time taken by a stopwatch.\n\nFaster walking speed indicates a better outcome. There is no lower and upper walking speed limits set for this measure.'}, {'measure': 'Numerical Pain Score', 'timeFrame': 'Week 0', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced)."}, {'measure': 'Numerical Pain Score', 'timeFrame': 'Week 3', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced)."}, {'measure': 'Numerical Pain Score', 'timeFrame': 'Week 7', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced)."}, {'measure': 'Numerical Pain Score', 'timeFrame': 'Week 11', 'description': "Measures pain subjectively from participant's rating. Scale is from 0 (indicating no pain experienced) to 10 (indicating worst pain experienced)."}, {'measure': 'Stroke Self-Efficacy Questionnaire', 'timeFrame': 'Week 0', 'description': 'Measures a stroke survivor\'s perceived level of confidence in functional performance.\n\nEach of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".\n\nThe points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.'}, {'measure': 'Stroke Self-Efficacy Questionnaire', 'timeFrame': 'Week 7', 'description': 'Measures a stroke survivor\'s perceived level of confidence in functional performance.\n\nEach of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".\n\nThe points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome.'}, {'measure': 'Stroke Self-Efficacy Questionnaire', 'timeFrame': 'Week 11', 'description': 'Measures a stroke survivor\'s perceived level of confidence in functional performance.\n\nEach of the 13 questions is scored on a 10-point scale (i.e. 0-10) with 0 indicating "Not At All Confident" and 10 indicating "Very Confident".\n\nThe points from the 13 questions are then added to get a total score, with a minimum score of 0 and a maximum score of 130. Higher score reflects a better outcome..'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Rehabilitation, Telerehabilitation, Virtual Reality'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'The use of virtual reality technology in a telerehabilitation service is not well established in Singapore. This feasibility trial aims to evaluate the benefits of using Jintronix to deliver a clinic-to-home, caregiver-supervised and individualised exercise telerehabilitation program to complement outpatient services and improve clinical outcomes for post-stroke users.', 'detailedDescription': "With the emphasis on improving population health, reducing the need for hospital care, and promoting self-management, it will be beneficial to make good use of current available technologies to complement centre-based therapy with cost effectiveness and efficiency.\n\nOne mode of such care delivery to a patient's home is through a telerehabilitation system that enables remote monitoring of patients' participation and performance in individualised home exercises. In addition, timely review and adjustments in the home programs to cater to progress or changes in patients' performance can be carried out by therapists remotely.\n\nIn the recent years, there has been an increased utilisation of virtual reality applications in physical rehabilitation for specific training objectives, such as, movement retraining, balance control and strength training. Virtual reality exercises when prescribed with defined training objectives and duration can potentially be valuable to increase patients' training intensity in the comfort of their own homes.\n\nThe majority of patients receiving outpatient and home based rehabilitation at Tan Tock Seng Hospital (TTSH) Rehabilitation Centre (RC) and Centre for Advanced Rehabilitation Therapeutics (CART) are patients who have had a stroke. Hence this group of outpatients that are at least 3 months post-stroke will be recruited for this trial. It is hypothesized that they will benefit from increased intensity of upper limb, balance and/or gait rehabilitation with Jintronix telerehabilitation system that facilitates them to further exercise at home and not just at the clinic.\n\nThe study is thus designed to evaluate the feasibility of a novel telerehabilitation service based on the Jintronix Virtual Reality Platform to complement existing outpatient therapy services of TTSH RC (including its outpatient service arm at CART)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with motor deficits due to stroke as diagnosed by CT or MRI, who are attending outpatient rehabilitation services at Tan Tock Seng Hospital Rehabilitation Centre and Centre for Advanced Rehabilitation Therapeutics\n* post stroke of at least 3 months with stable neurological status\n* 21-75 years old\n* able to perform at minimal level of assistance (i.e. carer provides only up to 25% of physical support) for sitting, standing and/or walking tasks\n* has a primary caregiver that must be present in all trial sessions\n* able to understand and participate in a 15 minutes Jintronix trial during screening\n\nExclusion Criteria:\n\n* has seizure history\n* has severe cognitive deficits, perceptual deficits, and/or emotional-behavioural issues\n* has unstable medical conditions which may affect participation (e.g unresolved sepsis, postural hypotension, end stage renal failure) or anticipated life expectancy of \\<1 year due to malignancy or neurodegenerative disorder\n* has pain score of \\>5\n* is pregnant or breastfeeding\n* has known poor cardiac ejection fraction (\\<30%) or lung function (FEV1\\<30%)\n* has non-weight bearing status in either lower extremities\n* has caregiver who is unable to meet competency requirements as assessed by study team'}, 'identificationModule': {'nctId': 'NCT04333758', 'briefTitle': 'Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System', 'organization': {'class': 'OTHER', 'fullName': 'Tan Tock Seng Hospital'}, 'officialTitle': 'Outpatient and Home Advanced Rehabilitation Therapeutics Using Jintronix Virtual Reality Telerehabilitation System', 'orgStudyIdInfo': {'id': 'NHG DSRB 2016/00442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jintronix Intervention', 'description': '2 consecutive phases of intervention for all participants using Jintronix virtual reality telerehabilitation software.\n\nPhase 1 consisted of 9 (3/week for 3 weeks) 45-min/session clinic-based sessions conducted by study team therapist, with concurrent caregiver training.\n\nPhase 2 consisted of 20 (5/week for 4 weeks) 45min/session home-based sessions supervised by trained caregiver, with telemonitoring by study team therapist.', 'interventionNames': ['Device: Jintronix Virtual Reality Telerehabilitation System']}], 'interventions': [{'name': 'Jintronix Virtual Reality Telerehabilitation System', 'type': 'DEVICE', 'otherNames': ['Jintronix'], 'description': "System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.\n\nStudy team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.\n\nTelemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training.", 'armGroupLabels': ['Jintronix Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': 'Centre for Advanced Rehabilitation Therapeutics, Tan Tock Seng Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Wee Keong Christopher Kuah, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tan Tock Seng Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Occupational Therapist', 'investigatorFullName': 'Kuah Wee Keong Christopher', 'investigatorAffiliation': 'Tan Tock Seng Hospital'}}}}