Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-01-05 @ 7:14 PM
Study NCT ID:
NCT03641651
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2018-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
New Technologies in the Rehabilitation of Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006429', 'term': 'Hemiplegia'}], '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'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108128', 'term': 'frovatriptan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'markus.wirz@zhaw.ch', 'phone': '+41 58 934', 'title': 'Prof. Dr. Markus Wirz', 'phoneExt': '6321', 'organization': 'Zurich University of applied sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'over the 4 weeks rehabilitation period', 'eventGroups': [{'id': 'EG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Correlation Between Scheduled and Performed Trainings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '0.61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': "Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Independence Measurement (FIM) Generic Functional Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '102', 'spread': '47.5', 'groupId': 'OG000'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '104.5', 'spread': '32.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Stroke Impact Scale (SIS) Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '50', 'spread': '35', 'groupId': 'OG000'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '65.5', 'spread': '17.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items.\n\neach item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can\'t do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Box and Block Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '0', 'spread': '19.8', 'groupId': 'OG000'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '1', 'spread': '30.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side.\n\nThe unit of the measure is the amount of blocks transferred within 60 seconds.', 'unitOfMeasure': 'blocks/60 sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Ambulation Categories (FAC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '10m Walk Test= TMT Comfortable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '28.6', 'spread': '22.9', 'groupId': 'OG000'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '19.0', 'spread': '19.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'time needed to walk 10 m with Comfortable walking speed', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '16', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '19', 'spread': '7.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The Walking Index consists of the 5 following items:\n\nWalking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes\n\nscored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Berg Balance Scale (BBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'classes': [{'title': 'pre-intervention', 'categories': [{'measurements': [{'value': '32', 'spread': '24', 'groupId': 'OG000'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '39', 'spread': '18.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'organizational issues at one study site', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Technology Arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.\n\nRehabilitation technology: •Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '60.8', 'spread': '12.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Switzerland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Paretic side', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Left side', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Right side', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Left /Right side', 'unitOfMeasure': 'Participants'}, {'title': 'Montreal Cognitive assessment (MoCA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '24.9', 'spread': '2.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '0-30 points on scale, more points meaning better cognitive function', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-09-12', 'size': 494629, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-08-15T11:03', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-08', 'studyFirstSubmitDate': '2018-08-13', 'resultsFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-08', 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation Between Scheduled and Performed Trainings', 'timeFrame': '4 weeks', 'description': "Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used."}], 'secondaryOutcomes': [{'measure': 'Functional Independence Measurement (FIM) Generic Functional Performance', 'timeFrame': 'Baseline and 4 weeks', 'description': 'observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent)'}, {'measure': 'Stroke Impact Scale (SIS) Recovery', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items.\n\neach item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can\'t do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding "recovery from stroke" rated on a scale from 0 - 100 (0= no recovery, 100= full recovery)'}, {'measure': 'Box and Block Test', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side.\n\nThe unit of the measure is the amount of blocks transferred within 60 seconds.'}, {'measure': 'Functional Ambulation Categories (FAC)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation)'}, {'measure': '10m Walk Test= TMT Comfortable', 'timeFrame': 'Baseline and 4 weeks', 'description': 'time needed to walk 10 m with Comfortable walking speed'}, {'measure': 'Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'The Walking Index consists of the 5 following items:\n\nWalking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes\n\nscored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better'}, {'measure': 'Berg Balance Scale (BBS)', 'timeFrame': 'Baseline and 4 weeks', 'description': 'Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Stroke', 'Hemiplegia']}, 'referencesModule': {'references': [{'pmid': '24756870', 'type': 'BACKGROUND', 'citation': 'Pollock A, Baer G, Campbell P, Choo PL, Forster A, Morris J, Pomeroy VM, Langhorne P. Physical rehabilitation approaches for the recovery of function and mobility following stroke. Cochrane Database Syst Rev. 2014 Apr 22;2014(4):CD001920. doi: 10.1002/14651858.CD001920.pub3.'}, {'pmid': '24505342', 'type': 'BACKGROUND', 'citation': 'Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.'}, {'pmid': '9238725', 'type': 'BACKGROUND', 'citation': 'Langhorne P, Wagenaar R, Partridge C. Physiotherapy after stroke: more is better? Physiother Res Int. 1996;1(2):75-88. doi: 10.1002/pri.6120010204.'}, {'pmid': '26338433', 'type': 'BACKGROUND', 'citation': 'Hornby TG, Holleran CL, Hennessy PW, Leddy AL, Connolly M, Camardo J, Woodward J, Mahtani G, Lovell L, Roth EJ. Variable Intensive Early Walking Poststroke (VIEWS): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2016 Jun;30(5):440-50. doi: 10.1177/1545968315604396. Epub 2015 Sep 3.'}, {'pmid': '26069298', 'type': 'BACKGROUND', 'citation': 'Knecht S, Rossmuller J, Unrath M, Stephan KM, Berger K, Studer B. Old benefit as much as young patients with stroke from high-intensity neurorehabilitation: cohort analysis. J Neurol Neurosurg Psychiatry. 2016 May;87(5):526-30. doi: 10.1136/jnnp-2015-310344. Epub 2015 Jun 11.'}, {'pmid': '10421300', 'type': 'BACKGROUND', 'citation': 'Kwakkel G, Wagenaar RC, Twisk JW, Lankhorst GJ, Koetsier JC. Intensity of leg and arm training after primary middle-cerebral-artery stroke: a randomised trial. Lancet. 1999 Jul 17;354(9174):191-6. doi: 10.1016/S0140-6736(98)09477-X.'}, {'pmid': '15001789', 'type': 'BACKGROUND', 'citation': 'Feys H, De Weerdt W, Verbeke G, Steck GC, Capiau C, Kiekens C, Dejaeger E, Van Hoydonck G, Vermeersch G, Cras P. 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No abstract available.'}, {'pmid': '35791026', 'type': 'BACKGROUND', 'citation': 'Schuster-Amft C, Kool J, Moller JC, Schweinfurther R, Ernst MJ, Reicherzer L, Ziller C, Schwab ME, Wieser S, Wirz M; SRTI study group. Feasibility and cost description of highly intensive rehabilitation involving new technologies in patients with post-acute stroke-a trial of the Swiss RehabTech Initiative. Pilot Feasibility Stud. 2022 Jul 5;8(1):139. doi: 10.1186/s40814-022-01086-0.'}]}, 'descriptionModule': {'briefSummary': 'The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high.\n\nThe evaluation focuses on feasibility and cost-benefit analyses', 'detailedDescription': 'This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with residual hemiparesis after cerebrovascular accident\n* Up to 12 months after the event\n* Primary rehabilitation terminated\n* Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)\n* General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician\n* Understand written and spoken German language\n\nExclusion Criteria:\n\nPatients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as\n\n* fixed joint contractures limiting range of motion\n* non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis\n\nSpecific absolute contraindication for the training with any of the respective devices:\n\n* Improper fit of the device, including its harness to relevant extremity(ies)\n* Contraindicated training position (standing, sitting)\n\nDevice specific contraindications will be respected and will lead to the exclusion of the device for that patient.'}, 'identificationModule': {'nctId': 'NCT03641651', 'acronym': 'SRTI', 'briefTitle': 'New Technologies in the Rehabilitation of Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Zurich University of Applied Sciences'}, 'officialTitle': 'Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative', 'orgStudyIdInfo': {'id': 'ZHAW-SRTI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technology arm', 'description': '4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.', 'interventionNames': ['Other: Rehabilitation technology']}], 'interventions': [{'name': 'Rehabilitation technology', 'type': 'OTHER', 'otherNames': ['Lokomat', 'Erigo', 'Andago', 'Armeo (Boom, Senseo, Spring, Power)', 'Valedo motion', 'Amadeo', 'Myro', 'NuStep', 'Bi-Manu Trainer', 'EksoGT', 'The Float', 'MOTOmed', 'Allegro'], 'description': '* Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.\n* With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).\n* A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.\n\nFive sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.\n\n* The training can take place in an outpatient or inpatient setting.\n* Training will be organized in individual one-to-one or group session', 'armGroupLabels': ['Technology arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4310', 'city': 'Rheinfelden', 'country': 'Switzerland', 'facility': 'Reha Rheinfelden', 'geoPoint': {'lat': 47.55437, 'lon': 7.79403}}, {'zip': '7317', 'city': 'Valens', 'country': 'Switzerland', 'facility': 'Kliniken Valens', 'geoPoint': {'lat': 46.96658, 'lon': 9.47705}}, {'zip': '8588', 'city': 'Zihlschlacht', 'country': 'Switzerland', 'facility': 'Rehakliniken Zihlschlacht', 'geoPoint': {'lat': 47.52065, 'lon': 9.25736}}, {'zip': '8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Klinik Lengg AG', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Markus Wirz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Klinik Lengg, Zurich', 'class': 'OTHER'}, {'name': 'Reha Rheinfelden', 'class': 'OTHER'}, {'name': 'Klinik Valens', 'class': 'OTHER'}, {'name': 'Rehaklinik Zihlschlacht AG', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Physiotherapy R&D', 'investigatorFullName': 'Markus Wirz', 'investigatorAffiliation': 'Zurich University of Applied Sciences'}}}}