Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT05436067
Status:
COMPLETED
Last Update Posted:
2025-04-24
First Post:
2022-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D004244', 'term': 'Dizziness'}], 'ancestors': [{'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'paulien.roos@cfd-research.com', 'phone': '256 715 6817', 'title': 'Dr. Paulien Roos', 'organization': 'CFD Research Corporation'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '90 minutes', 'eventGroups': [{'id': 'EG000', 'title': 'Older Adults With Dizziness', 'description': 'Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized.\n\nVestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perceived Usefulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Dizziness', 'description': 'Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized.\n\nVestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '1.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the testing', 'description': 'The ease of use of information technology questionnaire is used to rate usefulness and perceived ease of use of the Vestibular Rehabilitation app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'User Interface Satisfaction Questionnaire Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Dizziness', 'description': 'Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized.\n\nVestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.59', 'spread': '1.70', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the testing', 'description': 'The questionnaire for user interface satisfaction (QUIS) is used to rate the Vestibular Rehabilitation app on use of its software and screen. These are rated on a scale of 0-9, with 9 being the most positive response and 0 being the most negative response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Use Intention, Motivation and Enjoyment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Older Adults With Dizziness', 'description': 'Clinical trial only has one arm or participant group. All participants undergo the same experiment. They will perform exercises with the Vestibular Rehabilitation App as well as without the App. The order is randomized.\n\nVestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.90', 'spread': '1.13', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after the testing', 'description': 'A questionnaire on use intention, motivation, and enjoyment is used to rate the Vestibular Rehabilitation app on the use intention, motivation and enjoyment of the app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Head Angle With the App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'classes': [{'title': 'Peak pitch angle - left', 'categories': [{'measurements': [{'value': '13.2', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '22.0', 'spread': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Peak pitch angle - right', 'categories': [{'measurements': [{'value': '13.8', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '21.4', 'spread': '8.2', 'groupId': 'OG001'}]}]}, {'title': 'Peak yaw angle - flexion', 'categories': [{'measurements': [{'value': '13.6', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Peak yaw angle - extension', 'categories': [{'measurements': [{'value': '14.7', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '16.5', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in head angle pitch - left between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in head angle pitch - right between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in head angle yaw - extension between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.111', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in head angle yaw - flexion between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate peak head angles. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App.', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Range of Motion With the App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'classes': [{'title': 'Range of motion - yaw', 'categories': [{'measurements': [{'value': '14.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '7.0', 'groupId': 'OG001'}]}]}, {'title': 'Range of motion - pitch', 'categories': [{'measurements': [{'value': '13.6', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '22.9', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in pitch range of motion between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate head range of motion values. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Head Motion Frequency With the App', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'classes': [{'title': 'Pitch frequency', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.27', 'groupId': 'OG001'}]}]}, {'title': 'Yaw frequency', 'categories': [{'measurements': [{'value': '0.93', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in pitch velocity between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Difference in yaw velocity between the arms', 'groupDescription': 'This statistical analysis tests the difference between the different arms (with and without app) using a paired t-test', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate frequency of head motion. These were analyzed to identify differences for the conditions (arms) with and without the Vestibular Rehabilitation App', 'unitOfMeasure': 'Hz', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Balance Outcome With the App - Weight Shift Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'classes': [{'title': 'Weight shift exercise - mediolateral range of motion', 'categories': [{'measurements': [{'value': '8.7', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Weight shift exercise - anterioposterior range of motion', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Single leg balance - range of motion', 'categories': [{'measurements': [{'value': '8.8', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '6.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.035', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Weight shift exercise - mediolateral range of motion', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Weight shift balance exercise anteroposterior range of motion', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Single leg balance range of motion', 'statisticalMethod': 'paired t-test', 'nonInferiorityType': 'OTHER'}, {'pValue': '0.257', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Single leg balance fluency', 'statisticalMethod': 'Shapiro Wilcoxon test', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Data was not normally distributed.'}], 'paramType': 'MEAN', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate range of motion in different directions during the weight shift balance exercise (in degrees). These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Head Angle With Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'timeFrame': 'During the testing with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate peak head angles. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.', 'reportingStatus': 'POSTED', 'populationDescription': 'No participants were analyzed because too few participants received feedback during the trials. For participants that did receive feedback the time window before and after the feedback varied widely, since feedback could be provided at any point in time during the trial. Due to these inconsistencies it was decided not to perform any statistically analyses on these data or to extract and analyze these data.'}, {'type': 'PRIMARY', 'title': 'Change in Range of Motion With Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate range of motion values. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change.'}, {'type': 'PRIMARY', 'title': 'Change in Angular Velocity With Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate angular velocity values . Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change.'}, {'type': 'PRIMARY', 'title': 'Change in Balance Outcome With Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate balance measures (jerk). Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change.'}, {'type': 'PRIMARY', 'title': 'Error Identification Differences', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data were collected on this. The feedback was mostly provided at the start of the trial and because of this there was no time window before the feedback, which would be required to calculate the change.'}, {'type': 'SECONDARY', 'title': 'Open Ended Feedback', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.\n\nThis arm describes the results of the trials where exercises were performed with the Vestibular Rehabilitation App.\n\nVestibular rehabilitation app: Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.'}, {'id': 'OG001', 'title': 'Trials Without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.\n\nThis arm describes the results of the trials where exercises were performed without the Vestibular Rehabilitation App.\n\nTraditional Physical Therapy: Delivery of vestibular rehabilitation through traditional physical therapy.'}], 'classes': [{'title': 'Overall experience - not challenging', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - positive or fun', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - easy or easy to understand', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - engaging or interesting', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - motivating', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - difficult', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - seems geared toward more younger adults', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - not motivating', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - challenging (in a positive way)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Overall experience - reduced anxiety', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - fun', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - motivating', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - provides feedback', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - challenging', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - colorful', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - easy to use', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive features - helpful', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive feedback - seeing progress or accomplishments', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive feedback - liked scoring or rewards', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Positive feedback - liked the gaming element', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative features - none noted', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative features - feedback interrupted flow', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - redundant instructions', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - frustration with motion control', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - learning curve', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - transition from weight shifting to balance games was challenging', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - juvenile theme', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - longer setup than traditional therapy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - may get boring after a while', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Negative feedback - colors may be hard with color blindness in some games', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - motion sensing improvement', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - larger screen or font', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - more rewards', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - phone version', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - wider variety of games', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - nothing, good as is', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - sound effects', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - different theme', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - color blind accessibility', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - demo video / real human demonstration', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - personalization', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Would like - multi-player version', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - none', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - may be hard for older population to get used to technology', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - Setup at home and safety', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - learning how to use the app', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - equipment (tablet and stand) and equipment setup', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - cell phone version would be needed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - cost', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - needing family members to help with setup', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Barriers - adherence to exercises', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Immediately after the intervention', 'description': 'Participants will be asked for open ended feedback after the testing with and without the Vestibular Rehabilitation App. Discussions will be guided with questions. The questions were as follows: 1) Describe your overall experience as you used the app today?; 2) Explain the positive features of the app as you did your exercises?; 3) Describe the negative features of the app as you did your exercises today?; 4) What changes would you like to see in the app to support you as you do your exercises?; 5) Do you see any barriers to using the app while doing your exercises at home?', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The open ended questions referred to the use of the Vestibular Rehabilitation App and were therefore only filled out with regards to the arm "Trials with the Vestibular Rehabilitation App"'}, {'type': 'PRIMARY', 'title': 'Change in Balance Outcome With the App - Single Leg Balance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Trials With the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials with the Vestibular Rehabilitation App.'}, {'id': 'OG001', 'title': 'Trials Without the Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App and this occurred in the same lab visit. The order is randomized. these different trials with and without the app are presented as separate arms. This arms concerns the trials without the Vestibular Rehabilitation App.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.30', 'spread': '0.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate balance measure fluency (a non-dimensional derivative of jerk). This was analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App', 'unitOfMeasure': 'degrees', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Older Adults With Dizziness', 'description': 'All participants underwent the same experiment. They performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 40 participants were recruited and participated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Study Population', 'description': 'All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.\n\nIn the rest of the reporting the overall study population is presented in two different arms, "Trials with Vestibular Rehabilitation App" and "Trials without Vestibular Rehabilitation App". These are the same participants and all participated in both arms.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.65', 'spread': '4.76', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-04', 'size': 75044, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-02-06T10:48', 'hasProtocol': True}, {'date': '2022-03-04', 'size': 79512, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-06T10:59', 'hasProtocol': False}, {'date': '2022-03-04', 'size': 211402, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-06T11:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2022-06-06', 'resultsFirstSubmitDate': '2023-10-06', 'studyFirstSubmitQcDate': '2022-06-24', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-07', 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Usefulness', 'timeFrame': 'Immediately after the testing', 'description': 'The ease of use of information technology questionnaire is used to rate usefulness and perceived ease of use of the Vestibular Rehabilitation app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response.'}, {'measure': 'User Interface Satisfaction Questionnaire Outcomes', 'timeFrame': 'Immediately after the testing', 'description': 'The questionnaire for user interface satisfaction (QUIS) is used to rate the Vestibular Rehabilitation app on use of its software and screen. These are rated on a scale of 0-9, with 9 being the most positive response and 0 being the most negative response.'}, {'measure': 'Use Intention, Motivation and Enjoyment', 'timeFrame': 'Immediately after the testing', 'description': 'A questionnaire on use intention, motivation, and enjoyment is used to rate the Vestibular Rehabilitation app on the use intention, motivation and enjoyment of the app. These are rated on a scale of 1-7, with 1 being the most positive response, 4 being a neutral response and 7 being the most negative response.'}, {'measure': 'Change in Head Angle With the App', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate peak head angles. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App.'}, {'measure': 'Change in Range of Motion With the App', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate head range of motion values. These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App'}, {'measure': 'Change in Head Motion Frequency With the App', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate frequency of head motion. These were analyzed to identify differences for the conditions (arms) with and without the Vestibular Rehabilitation App'}, {'measure': 'Change in Balance Outcome With the App - Weight Shift Exercise', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate range of motion in different directions during the weight shift balance exercise (in degrees). These were analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App'}, {'measure': 'Change in Head Angle With Feedback', 'timeFrame': 'During the testing with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate peak head angles. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.'}, {'measure': 'Change in Range of Motion With Feedback', 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate range of motion values. Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.'}, {'measure': 'Change in Angular Velocity With Feedback', 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate angular velocity values . Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.'}, {'measure': 'Change in Balance Outcome With Feedback', 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with the Vestibular Rehabilitation App will be analyzed to calculate balance measures (jerk). Averages will be calculated for time windows before and after feedback on exercise performance is given. This will be analyzed to identify differences before and after feedback has been given.'}, {'measure': 'Error Identification Differences', 'timeFrame': 'During the intervention with the app (up to 45 minutes)', 'description': 'The exercise errors that are identified by the Vestibular Rehabilitation App and those identified by the physical therapist will be compared.'}, {'measure': 'Change in Balance Outcome With the App - Single Leg Balance', 'timeFrame': 'During the testing with the app and during the testing without the app (up to 90 minutes)', 'description': 'The IMU sensor data collected during the exercise performance with and without the Vestibular Rehabilitation App (collected in the same lab visit on the same group of participants) were analyzed to calculate balance measure fluency (a non-dimensional derivative of jerk). This was analyzed to identify differences for the conditions with and without the Vestibular Rehabilitation App'}], 'secondaryOutcomes': [{'measure': 'Open Ended Feedback', 'timeFrame': 'Immediately after the intervention', 'description': 'Participants will be asked for open ended feedback after the testing with and without the Vestibular Rehabilitation App. Discussions will be guided with questions. The questions were as follows: 1) Describe your overall experience as you used the app today?; 2) Explain the positive features of the app as you did your exercises?; 3) Describe the negative features of the app as you did your exercises today?; 4) What changes would you like to see in the app to support you as you do your exercises?; 5) Do you see any barriers to using the app while doing your exercises at home?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['balance', 'telehealth', 'physical therapy', 'mobile application', 'serious gaming', 'rehabilitation', 'vestibular', 'dizziness'], 'conditions': ['Vestibular Disorder', 'Balance; Distorted', 'Vestibular Diseases']}, 'referencesModule': {'references': [{'pmid': '35280295', 'type': 'BACKGROUND', 'citation': 'DSilva LJ, Skop KM, Pickle NT, Marschner K, Zehnbauer TP, Rossi M, Roos PE. Use of Stakeholder Feedback to Develop an App for Vestibular Rehabilitation-Input From Clinicians and Healthy Older Adults. Front Neurol. 2022 Feb 24;13:836571. doi: 10.3389/fneur.2022.836571. eCollection 2022.'}, {'type': 'BACKGROUND', 'citation': 'Davis, F. D. Perceived Usefulness, Perceived Ease of Use, and User Acceptance of Information Technology. MIS Quarterly. 1989; 13(3): 319-340.'}, {'type': 'BACKGROUND', 'citation': "Chin, J.P., Diehl, V.A., and Norman, K.L. Development of a tool measuring user satisfaction of the human-computer interface. CHI '88: Proceedings of the SIGCHI Conference on Human Factors in Computing Systems. 1988; 213-218."}, {'pmid': '24966165', 'type': 'BACKGROUND', 'citation': 'van Het Reve E, Silveira P, Daniel F, Casati F, de Bruin ED. Tablet-based strength-balance training to motivate and improve adherence to exercise in independently living older people: part 2 of a phase II preclinical exploratory trial. J Med Internet Res. 2014 Jun 25;16(6):e159. doi: 10.2196/jmir.3055.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test whether when using the Vestibular Rehabilitation App older patients perform rehabilitation in a similar manner as when directly instructed by a clinician. A secondary goal is to evaluate usability and enjoyment of the app.', 'detailedDescription': 'The main aim of this study is to test the prototype Vestibular Rehabilitation App (that has been specifically developed for this study) in the lab setting to evaluate if patients perform exercises with the app in a similar manner as when performing exercises in the traditional manner without the app. Errors in exercise performance identified by the app will be compared to those identified by a physical therapist. A secondary aim is to get feedback on enjoyment and ease of use of the Vestibular Rehabilitation App.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* aged between 60 and 75\n* Presence of dizziness due to a central or peripheral vestibular disorder\n\nExclusion Criteria:\n\n* Presence of neurological disease such as stroke, multiple sclerosis, Parkinson's\n* History of recent lower extremity surgery or severe pain in legs"}, 'identificationModule': {'nctId': 'NCT05436067', 'briefTitle': 'Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements', 'organization': {'class': 'INDUSTRY', 'fullName': 'CFD Research Corporation'}, 'officialTitle': 'Evaluation of an App for Individualized Vestibular Rehabilitation for Elderly With Self-Management and Gaming Elements', 'orgStudyIdInfo': {'id': 'STUDY00148324'}, 'secondaryIdInfos': [{'id': '5R44DC017408-03', 'link': 'https://reporter.nih.gov/quickSearch/5R44DC017408-03', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trials with Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.\n\nThis arm describes the results of the trials where exercises were performed with the Vestibular Rehabilitation App.', 'interventionNames': ['Device: Vestibular rehabilitation app']}, {'type': 'EXPERIMENTAL', 'label': 'Trials without Vestibular Rehabilitation App', 'description': 'All participants underwent the same experiment. They will performed exercises with the Vestibular Rehabilitation App as well as without the App. The order was randomized.\n\nThis arm describes the results of the trials where exercises were performed without the Vestibular Rehabilitation App.', 'interventionNames': ['Other: Traditional Physical Therapy']}], 'interventions': [{'name': 'Vestibular rehabilitation app', 'type': 'DEVICE', 'description': 'Delivery of vestibular rehabilitation through an app on a tablet or other portable device. The app takes patients through their rehabilitation session that has been prescribed by a clinician. Exercises are presented in the forms of games that are controlled by head or torso motion via a motion sensor that is placed on that body part. Data on the motion of the patient are calculated from sensor data and sent over the cloud for the clinician to access remotely.', 'armGroupLabels': ['Trials with Vestibular Rehabilitation App']}, {'name': 'Traditional Physical Therapy', 'type': 'OTHER', 'description': 'Delivery of vestibular rehabilitation through traditional physical therapy.', 'armGroupLabels': ['Trials without Vestibular Rehabilitation App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Paulien Roos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CFD Research Corporation'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will be available upon request after they have been published', 'ipdSharing': 'YES', 'description': 'All resources developed for this project will be presented at conferences and published in the literature where possible. Whenever possible the investigators will include supplemental data (de-identified) in the online versions of their publications to most fully disseminate our results. Also, resources and de-identified data will be made available, whenever possible and appropriate, to qualified persons upon request.', 'accessCriteria': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CFD Research Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Deafness and Other Communication Disorders (NIDCD)', 'class': 'NIH'}, {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}