Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-01-01 @ 3:34 AM
Study NCT ID:
NCT05159635
Status:
COMPLETED
Last Update Posted:
2021-12-16
First Post:
2021-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D020427', 'term': 'Peroneal Neuropathies'}], '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': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-10', 'studyFirstSubmitDate': '2021-08-04', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change score in Stroke Adapted 30 item version of the Sickness Impact Profile (SA-SIP 30)', 'timeFrame': 'before intervention, 8 weeks (after intervention )', 'description': 'The quality of life scale for the people with stroke'}], 'secondaryOutcomes': [{'measure': 'Change score in 10 meters walk Test', 'timeFrame': 'before intervention,8 weeks (after intervention)', 'description': '10 meters walk time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Wearable'], 'conditions': ['Stroke', 'Foot Drop (Acquired)']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the effectiveness of adopting a home-use Wearable Technical Aids (WTA) with the structured Active Living Program (ALP) to promote community participation in young stroke patients.', 'detailedDescription': 'Two groups of patients would receive Wearable Technical Aids Training or Wearable Technical Aids Training and structured Active Living Program (ALP) for 8 sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-diagnosed with foot drop with tibialis anterior muscle strength between 1 to 3- out of 5 in manual muscle testing for more than six months due to cerebrovascular accident (CVA)\n\nExclusion Criteria:\n\n* pre-existing orthopedic conditions affecting ambulation\n* subjects who are incompetent in giving written consent'}, 'identificationModule': {'nctId': 'NCT05159635', 'briefTitle': 'Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA)', 'organization': {'class': 'OTHER', 'fullName': 'Kowloon Hospital, Hong Kong'}, 'officialTitle': 'The Effectiveness of Combining Active Living Programme (ALP) With Home-Use Wearable Technical Aids (WTA) to Promote Community Participation in Young Stroke With Foot Drop Problem- The Pilot Study', 'orgStudyIdInfo': {'id': 'KC/KE-17-0187/FR-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active Living programme and wearable technical aids', 'description': 'Active Living programme and wearable technical aids', 'interventionNames': ['Device: Active Living programme and wearable technical aids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Wearable technical aids', 'description': 'Wearable technical aids', 'interventionNames': ['Device: Wearable technical aids']}], 'interventions': [{'name': 'Active Living programme and wearable technical aids', 'type': 'DEVICE', 'description': 'attend 6 weeks active living programme and apply wearable technical aids for 8 weeks.', 'armGroupLabels': ['Active Living programme and wearable technical aids']}, {'name': 'Wearable technical aids', 'type': 'DEVICE', 'description': 'apply wearable technical aids for 8 weeks.', 'armGroupLabels': ['Wearable technical aids']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kowloon', 'country': 'Hong Kong', 'facility': 'Community Rehabilitation Service Support Centre', 'geoPoint': {'lat': 22.31667, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Marko Chan, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Community Rehabilitation Service Supoort Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowloon Hospital, Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kwong Wah Hospital', 'class': 'OTHER'}, {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Occupational Therapist', 'investigatorFullName': 'Marko Chan', 'investigatorAffiliation': 'Kowloon Hospital, Hong Kong'}}}}