Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2026-01-24 @ 3:53 PM
Study NCT ID:
NCT03282968
Status:
COMPLETED
Last Update Posted:
2023-12-05
First Post:
2017-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Balance Training After Stroke With REWIRE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2017-09-12', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in walking speed', 'timeFrame': 'Assessment one day before and one day after the program', 'description': 'Assessed using 10 Meter Walking Test'}, {'measure': 'Change in dynamic balance', 'timeFrame': 'Assessment one day before and one day after the program', 'description': 'Assessed using Four Step Square Test'}], 'secondaryOutcomes': [{'measure': 'Change in mobility', 'timeFrame': 'Assessment one day before and one day after the program', 'description': 'Assessed using Timed Up and Go test'}, {'measure': 'Change in static standing balance', 'timeFrame': 'Assessment one day before and one day after the program', 'description': 'Assessed using Romberg test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['exergaming', 'physiotherapy', 'balance'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '32300321', 'type': 'DERIVED', 'citation': 'Cikajlo I, Rudolf M, Mainetti R, Borghese NA. Multi-Exergames to Set Targets and Supplement the Intensified Conventional Balance Training in Patients With Stroke: A Randomized Pilot Trial. Front Psychol. 2020 Apr 2;11:572. doi: 10.3389/fpsyg.2020.00572. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The study will include 20 patients after stroke, randomly assigned to the experimental and control group (10 each). In both groups, the program with last for five days; walking and balance will be assessed before and after the program. Both groups will receive regular neurophysiotherapy; in addition, the experimental group will exercise each day by playing REWIRE games, while the control group will perform standing balance exercises.', 'detailedDescription': 'Detailed inclusion and exclusion criteria are specified in the appropriate section. Both groups will perform the additional exercises for 15 minutes daily. In addition to the outcome measurement, informal feedback will be obtained from the patients and the therapists on the feasibility of the REWIRE system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first stroke\n* first admission to inpatient rehabilitation\n\nExclusion Criteria:\n\n* less than 25 points scored on the Mini-Mental State Examination\n* inability to walk independently'}, 'identificationModule': {'nctId': 'NCT03282968', 'acronym': 'REWIRESI', 'briefTitle': 'Balance Training After Stroke With REWIRE', 'organization': {'class': 'OTHER', 'fullName': 'University Rehabilitation Institute, Republic of Slovenia'}, 'officialTitle': 'Balance Training With the Rehabilitative Wayout In Responsive Home Environments (REWIRE) System in Patients After Stroke', 'orgStudyIdInfo': {'id': 'URIS201704'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Regular neurophysiotherapy plus REWIRE exercises', 'interventionNames': ['Device: REWIRE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Regular neurophysiotherapy plus standing balance exercises', 'interventionNames': ['Other: Balance exercises']}], 'interventions': [{'name': 'REWIRE', 'type': 'DEVICE', 'description': 'First, the patient will play the Fruit Catcher (weight transfer) game on the 3rd level for 3 minutes, followed by 3 minutes of rest. Next, the patient will play the Horse Runner (squats) on the 3rd level for 3 minutes, followed by 3 minutes of rest. In the end, the patient will play the Animal Hurdler (standing on one leg) on the 3rd level for 3 minutes. During the games, the patient will be standing on the Wii Balance Board, holding to a firm support if necessary. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.', 'armGroupLabels': ['Experimental']}, {'name': 'Balance exercises', 'type': 'OTHER', 'description': 'The patient will first practice balance transfer for 3 minutes (standing by a ladder, holding position on each leg for 3 seconds), followed by 3 minutes of rest. Next, the patient will be performing squats for 3 minutes, followed by 3 minutes of rest. In the end, the patient will practice alternatively lifting lower limbs (like stepping on a footstool) for 3 minutes. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'University Rehabilitation Institute, Republic of Slovenia', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Imre Cikajlo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Rehabilitation Institute, Rehabilitation of Slovenia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Rehabilitation Institute, Republic of Slovenia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jozef Stefan Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}