Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-02 @ 1:46 AM
Study NCT ID:
NCT03183635
Status:
COMPLETED
Last Update Posted:
2020-12-11
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rapid Movement Therapy for Stroke Rehabilitation
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-10', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2017-06-08', 'lastUpdatePostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Berg Balance Scale (BBS)', 'timeFrame': '3-month follow-up', 'description': 'A 14-item objective measure designed to assess static balance and fall risk in adult populations'}, {'measure': 'Timed Up and Go (TUG)', 'timeFrame': '3-month follow-up', 'description': 'It is used to assess mobility, balance, walking ability, and fall risk in older adults'}], 'secondaryOutcomes': [{'measure': 'Fugl-Meyer Assessment (FMA) of Motor Recovery after Stroke', 'timeFrame': '3-month follow-up', 'description': 'It is used to evaluate and measure recovery in post-stroke hemiplegic patients'}, {'measure': 'Activities-specific Balance Confidence (ABC) Scale', 'timeFrame': '3-month follow-up', 'description': 'Subjective measure of confidence in performing various ambulatory activities without falling or experiencing a sense of unsteadiness'}, {'measure': 'Barthel Index of Activities of Daily Living', 'timeFrame': '3-month follow-up', 'description': 'It is used to assess the ability of an individual with a neuromuscular or musculoskeletal disorder to care for him/herself'}, {'measure': 'Electromyography (EMG)', 'timeFrame': '3-month follow-up', 'description': 'It is used to detect the muscle activity'}, {'measure': '"lean-and-release" postural system', 'timeFrame': '3-month follow-up', 'description': 'It is used to evaluate balance-recovery in chronic stroke patients. Participants will wear a safety harness designed to prevent impact between body and floor, and they will be asked to stand on two force plates in standardized stance and lean forward with around 10% body weight supported by a cable attached to a release mechanism. Compensatory balance-recovery reactions will be evoked by the sudden release of the support cable, inducing a forward fall. Participants will be evaluated under three different conditions: no handrail, handrail on the unaffected side, and handrail on the affected side.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '34635141', 'type': 'DERIVED', 'citation': 'Junata M, Cheng KC, Man HS, Lai CW, Soo YO, Tong RK. Kinect-based rapid movement training to improve balance recovery for stroke fall prevention: a randomized controlled trial. J Neuroeng Rehabil. 2021 Oct 11;18(1):150. doi: 10.1186/s12984-021-00922-3.'}]}, 'descriptionModule': {'briefSummary': "Stroke survivors have higher risks of falling compared to other healthy non-stroke adults. Stroke patients' balance can be trained by Kinect-based training that enable user friendly and interactive training."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. have single stroke with onset \\>1 year,\n2. have unilateral paresis,\n3. are 50 years of age or older,\n4. able to stand without aid for at least 15min,\n5. have moderate level of motor impairment in the affective upper limb, i.e. 15≤ Fugl-Meyer Assessment for upper-extremity(FMA-UE) ≤ 45,\n6. have some level of deficit in balance control, i.e. Berg Balance Scale(BBS)\\< 52/56,\n7. have a minimum Snellen visual acuity of 20/40 with/without spectacles,\n8. have a minimum Mini-Mental-Status-Examination score of 22/30, and\n9. have to be able to follow the training procedures.\n\nExclusion Criteria:\n\n1. enrolled in other rehabilitation program in the study duration,\n2. have other neurological conditions in addition to stroke (e.g. Parkinson's disease),\n3. have unstable cardiovascular disease (e.g. history of heart disease, or poorly controlled hypertension, i.e. blood pressure \\>160mmHg/100mmHg), or\n4. have other serious diseases or conditions (e.g. osteoporosis, recent joint replacement surgery, amputation) that preclude them from participating in the study."}, 'identificationModule': {'nctId': 'NCT03183635', 'briefTitle': 'Rapid Movement Therapy for Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A Randomized Controlled Trial of Rapid Movement Therapy With Real-time Feedback to Improve Balance Recovery for Fall Prevention After Stroke', 'orgStudyIdInfo': {'id': '12131911'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kinect based Rapid Movement Therapy', 'description': 'Kinect based Rapid Movement Therapy (RMT) training requires participants to move their limbs very rapidly to reach-to-grasp or step towards a virtual target appear suddenly on a screen, which is designed to their range of motion as well as response speed.', 'interventionNames': ['Procedure: Balance training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional balance training', 'description': 'Conventional balance training involves some slow and low-impact muscle strengthening and mobilizing exercises.', 'interventionNames': ['Procedure: Balance training']}], 'interventions': [{'name': 'Balance training', 'type': 'PROCEDURE', 'description': 'Improvement of balance ability in stroke patients', 'armGroupLabels': ['Conventional balance training', 'Kinect based Rapid Movement Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Department of Biomedical Engineering, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Raymond Kai-yu Tong, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Biomedical Engineering, CUHK'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Raymond KY Tong', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}