Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT01644292
Status:
COMPLETED
Last Update Posted:
2023-11-30
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ed.Giesbrecht@med.umanitoba.ca', 'phone': '204-977-5630', 'title': 'Ed Giesbrecht', 'organization': 'University of Manitoba'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Training Intervention', 'description': 'EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.', 'otherNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Training Intervention', 'description': 'EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.25', 'spread': '8.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and follow-up (1 month)', 'description': 'The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Training Intervention', 'description': 'EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Training Intervention', 'description': 'EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.5', 'spread': '9.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2012-07-13', 'resultsFirstSubmitDate': '2013-08-12', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-01-20', 'studyFirstPostDateStruct': {'date': '2012-07-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Wheelchair Skills Test (WST) 4.1 Capacity Score', 'timeFrame': 'Baseline and follow-up (1 month)', 'description': 'The WST is a structured assessment with 32 discrete mobility skills required to perform social roles in the community, each scored dichotomously as pass/fail. The WST produces a total Skill Capacity score (0-100%) reflecting the number of skills safely passed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mobility Impairment', 'Manual Wheelchair', 'Older Adults'], 'conditions': ['Older Adult Manual Wheelchair Users']}, 'referencesModule': {'references': [{'pmid': '28582240', 'type': 'DERIVED', 'citation': 'Giesbrecht EM, Miller WC, Jin BT, Mitchell IM, Eng JJ. Rehab on Wheels: A Pilot Study of Tablet-Based Wheelchair Training for Older Adults. JMIR Rehabil Assist Technol. 2015 Apr 30;2(1):e3. doi: 10.2196/rehab.4274.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to conduct a pilot study of the EPIC WheelS wheelchair skills home training program for older adults in preparation for a third phase feasibility study.', 'detailedDescription': 'Many older adults rely on a manual wheelchair for community mobility but are not provided with skills for independent and effective use. Suboptimal or disuse of the wheelchair results in substantial social costs such as reduced engagement in meaningful activity, social isolation, and higher caregiver burden. This represents a poor use of financial resources, including the cost of wheelchair acquisition and demands for attendant care. Access to skills training is constrained by the cost and limited availability of skilled therapists, the demands of patient and clinician travel, and lack of programs designed specifically for the needs of older adults. Enhancing Participation In the Community by improving Wheelchair Skills (EPIC WheelS) is an individualized home-training program that optimizes learning for older adults while limiting the demands on expert clinician trainers. It is delivered using a portable computer tablet that allows interactive learning, customized updating, and communication with an expert trainer. A monitored, home program that is effective and efficient for older adults has potential application for other target groups as well, particularly those with limited access to rehabilitation services in rural and remote locations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 50 years old\n* live in the community within metropolitan Winnipeg\n* self-propel a MWC (Manual Wheelchair) at least 1 hour per day\n* use their MWC for mobility outside of the home\n* have used a MWC for less than 2 years\n\nExclusion Criteria:\n\n* cannot communicate and complete study questionnaires in English\n* anticipate a health condition that contraindicates wheelchair training'}, 'identificationModule': {'nctId': 'NCT01644292', 'acronym': 'EPIC WheelS', 'briefTitle': 'Enhancing Participation In the Community by Improving Wheelchair Skills: Phase 2', 'organization': {'class': 'OTHER', 'fullName': 'University of Manitoba'}, 'officialTitle': 'Enhancing Participation In the Community by Improving Wheelchair Skills (EPIC WheelS): Phase 2', 'orgStudyIdInfo': {'id': 'H2012:069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EPIC Wheels Training Intervention', 'description': 'EPIC Wheels skills training program', 'interventionNames': ['Other: EPIC WheelS']}], 'interventions': [{'name': 'EPIC WheelS', 'type': 'OTHER', 'description': 'EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.', 'armGroupLabels': ['EPIC Wheels Training Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R3E 0T6', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'University of Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'overallOfficials': [{'name': 'Ed M Giesbrecht, PhD (Cand.)', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Manitoba'}, {'name': 'William C Miller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Janice Eng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manitoba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}