Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-28 @ 10:50 PM
Study NCT ID:
NCT04238260
Status:
COMPLETED
Last Update Posted:
2025-05-21
First Post:
2020-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhancing Physical Therapy Best Practice for Improving Walking After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Assessors at each site will be blinded to intervention. Site study coordinators will be unblinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This clinical trial uses a stepped-wedge design. Unlike typical studies where participants are randomized to two different interventions, this design has all sites start in the Usual Care period, and then switch-over to Enhanced Care at predetermined times, which will then be the new Usual Care (termed "Enhanced Usual Care").'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-15', 'studyFirstSubmitDate': '2020-01-20', 'studyFirstSubmitQcDate': '2020-01-20', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Six-minute walk Test', 'timeFrame': '4 weeks', 'description': 'This test measures distance a participant can walk in 6 minutes.'}], 'secondaryOutcomes': [{'measure': 'Six-minute walk test', 'timeFrame': '12 months post-stroke', 'description': 'This test measures distance a participant can walk in 6 minutes.'}, {'measure': 'Blood pressure', 'timeFrame': '4 weeks & 12 months post-stroke', 'description': 'Blood pressure measures physiological effects of the intervention'}, {'measure': 'Euro-QOL 5D-5L', 'timeFrame': '4 weeks & 12 months post-stroke', 'description': 'This test is the most widely used instrument to measure quality of life.'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': '4 weeks & 12 months post-stroke', 'description': 'This test measures levels of cognitive function.'}, {'measure': 'Short performance physical battery', 'timeFrame': '4 weeks & 12 months post-stroke', 'description': 'This test measures levels of lower extremity function.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '4 weeks & 12 months post-stroke', 'description': 'This test screens for depression'}, {'measure': 'Modified Rankin Scale (mRS)', 'timeFrame': '4 weeks & 12 months post-stroke', 'description': 'This scale measures the degree of disability. Score range: minimum 0 to maximum 6. Lower score means a better outcome.'}, {'measure': 'Physical Activity Scale for the Elderly (PASE)', 'timeFrame': '12 months post-stroke', 'description': 'This test assesses physical activity, including leisure, household, and occupational activity. Score range: minimum 0 to maximum 400 or more. Higher score means a better outcome'}, {'measure': 'Step activity monitor', 'timeFrame': '12 months post stroke', 'description': 'The number of steps per day over 3 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Lower extremity', 'Rehabilitation', 'Wearable device', 'Exercise', 'Clinical Trial'], 'conditions': ['Stroke', 'Cerebral Infarction', 'Brain Ischemia', 'Infarction, Brain']}, 'referencesModule': {'references': [{'pmid': '41139309', 'type': 'DERIVED', 'citation': 'Hung SH, Ackerley S, Connell LA, Bayley MT, Best KL, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Peters S, Sakakibara BM, Sheehy L, Yao J, Eng JJ. Real-World Experiences of Therapy Staff Implementing an Intensive Rehabilitation Protocol in Canadian Stroke Inpatient Rehabilitation Settings: A Multi-Site Survey Study. Phys Ther. 2025 Oct 1;105(10):pzaf111. doi: 10.1093/ptj/pzaf111.'}, {'pmid': '40720450', 'type': 'DERIVED', 'citation': 'Yan Y, Eng JJ, Hung SH, Bayley MT, Best KL, Connell LA, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Sakakibara BM, Sheehy L, Wong H, Yao J, Peters S. Aerobic minutes and step number remain low in inpatient stroke rehabilitation. PLoS One. 2025 Jul 28;20(7):e0328930. doi: 10.1371/journal.pone.0328930. eCollection 2025.'}, {'pmid': '40683274', 'type': 'DERIVED', 'citation': "Peters S, Hung SH, Bayley MT, Best KL, Connell LA, Donkers SJ, Dukelow SP, Ezeugwu VE, Milot MH, Sakakibara BM, Sheehy L, Wong H, Yang Y, Yao J, Eng JJ. Safety and effectiveness of the Walk 'n Watch structured, progressive exercise protocol delivered by physical therapists for inpatient stroke rehabilitation in Canada: a phase 3, multisite, pragmatic, stepped-wedge, cluster-randomised controlled trial. Lancet Neurol. 2025 Aug;24(8):643-655. doi: 10.1016/S1474-4422(25)00201-7."}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess the effect of implementing best practices into current stroke rehabilitation physical therapy on walking outcomes. Participants will also be provided an activity monitor to help them track and target their walking practice to determine if this can improve walking ability.', 'detailedDescription': "This multi-site study will have each site start in usual care with participants consented to collecting outcome measures. The twelve inpatient stroke units include: Kelowna General Hospital, Nanaimo Regional General Hospital, Glenrose Rehabilitation Hospital, Saskatoon City Hospital, Wascana Rehabilitation Centre, Joseph Brant Hospital, Bruyère Hospital, Freeport Grand River Hospital, CIUSSS-de-l'Estrie-CHUS Centre de réadaptation de l'Estrie, Centre interdisciplinaire de recherche en réadaptation et intégration sociale, Dr. Everett Chalmers Regional Hospital, and Queen Elizabeth Hospital. Each site will randomly switch over to Enhanced Usual Care (best practice implementation) where all physical therapists at the site will be educated on delivery of best practice for locomotor retraining. The specific therapy activities are at the discretion of the physical therapist; however, physical therapists must work towards thirty minutes of weight-bearing/stepping activity at greater than forty percent heart rate reserve. Participants will continue to be consented to collecting outcome measures. Additionally, participants will be given and trained to use activity watches to monitor their own progress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Admitted by inpatient or day stroke rehabilitation\n* Improved walking is a rehabilitation goal\n* Within 12 weeks post hemorrhagic or ischemic CVA with hemiparesis (confirmed by medical chart or motor assessment)\n* Able to ambulate at least 5 steps. May use assistive and/or orthotic device and maximum one person assist\n* Overground walking speed slower than normal\n* Able to understand and follow directions\n* Greater than or equal to 19 years of age\n* Medically stable\n\nExclusion Criteria:\n\n* Pre-stroke health included a serious gait disorder or disease that affected ambulation (musculoskeletal conditions, amputation, surgery/arthroplasty in the last 6 months, etc.)\n* Pre-stroke health included a neurological condition (such as Parkinson's disease or Multiple Sclerosis) or other serious medical condition (active cancer, uncontrolled diabetes)\n* Excessive pain in the body/joint preventing participation in an exercise intervention\n* Participating in an experimental drug field study\n* Participating in another formal exercise rehabilitation clinical trial\n* Expected to receive \\<2 weeks daily in-/out- patient rehabilitation"}, 'identificationModule': {'nctId': 'NCT04238260', 'briefTitle': 'Enhancing Physical Therapy Best Practice for Improving Walking After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Enhancing Physical Therapy Best Practice for Improving Walking After Stroke', 'orgStudyIdInfo': {'id': 'H19-02809'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Usual Physical Therapy Care', 'description': 'Physical Therapists continue usual care', 'interventionNames': ['Behavioral: Physical Therapy Usual Care']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Physical Therapy Usual Care', 'description': 'Best practice implemented', 'interventionNames': ['Behavioral: Enhancing Physical Therapy Usual Care']}], 'interventions': [{'name': 'Enhancing Physical Therapy Usual Care', 'type': 'BEHAVIORAL', 'description': 'The protocol is focused on the completion of a minimum of 30 minutes of weight-bearing, walking-related activities that progressively increase in intensity informed by heart rate and step counters over 4 weeks.', 'armGroupLabels': ['Enhanced Physical Therapy Usual Care']}, {'name': 'Physical Therapy Usual Care', 'type': 'BEHAVIORAL', 'description': 'Usual physical therapy', 'armGroupLabels': ['Usual Physical Therapy Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z2G9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Janice J Eng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'If required by journal for publication, the following individual participant data will be entered into a repository: age in years, sex, and outcomes as described above.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Janice Eng', 'investigatorAffiliation': 'University of British Columbia'}}}}