Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT01432418
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2011-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009069', 'term': 'Movement Disorders'}], 'ancestors': [{'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-06', 'studyFirstSubmitDate': '2011-09-08', 'studyFirstSubmitQcDate': '2011-09-09', 'lastUpdatePostDateStruct': {'date': '2016-05-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Wheelchair Skills, WST 4.1 questionnaire version', 'timeFrame': 'baseline, 1 month , 3 months', 'description': "A measure of what the person 'can do' (capacity), 'does do' (performance), and the safety of various wheelchair skills. The Wheelchair Skills Test (WST) version 4.1 in questionnaire format will be used."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['rehabilitation', 'wheelchairs', 'safety', 'disability evaluation', 'motor skills'], 'conditions': ['Movement Disorders']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674291/?tool=nihms', 'label': 'pubmed Canada study results'}]}, 'descriptionModule': {'briefSummary': 'This is a 3-year multi-centre, single-blinded, randomized controlled trial (RCT) to test the hypothesis that wheelchair skills training (using a systematic training program called the Wheelchair Skills Training Program) improves wheelchair skills and safety of 144 powered wheelchair users. A second objective is to assess the effects of age, sex, training centre, and participant experience on outcomes, assessing the retention of benefits and assessing the impact of training on other important outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* new or experienced powered wheelchair users\n* use or are expected to use powered wheelchairs for at least 4 hrs/week\n* have access to a powered wheelchair with a suitable range of controller settings (i.e. able to climb a 5cm level change) for testing and training\n* equal or greater than 18 years of age\n* able to follow directions in either French or English (whichever is in use at the participating site)\n* have the potential to operate their powered wheelchairs independently\n* have room for improvement (in the opinion of the potential participant's clinician)\n* requires no more than minimal assistance for communication and auditory comprehension (in the opinion of the potential participant's clinician)\n* able to follow 2-step commands\n* demonstrate the ability to attend training sessions during the intake session\n* competent to provide their own informed consent\n* able to be comfortably seated in the powered wheelchairs that will be used for the study (if not their own).\n\nExclusion Criteria:\n\n* use or are expected to use a scooter\n* have a rapidly progressive disorder (e.g. amyotrophic lateral sclerosis or terminal cancer)\n* have significant visual impairments (legally blind)\n* have unstable medical conditions (e.g. angina, seizures)\n* have emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant"}, 'identificationModule': {'nctId': 'NCT01432418', 'briefTitle': 'Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Nova Scotia Health Authority'}, 'officialTitle': 'Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '230378'}, 'secondaryIdInfos': [{'id': 'CDHA-RS/2012-133', 'type': 'OTHER', 'domain': 'Capital Health Ethics Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'wheelchair training', 'interventionNames': ['Other: Wheelchair skills training program']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care only'}], 'interventions': [{'name': 'Wheelchair skills training program', 'type': 'OTHER', 'description': 'A training program that uses methods based on the rehabilitation, wheelchair, and motor skills literature to teach wheelchair skills.', 'armGroupLabels': ['wheelchair training']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 2G9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'GFS Rehabilitation Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H 4K4', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Rehabilitation Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'N6G 1H1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Western Ontario', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G 1V7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehab', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2H 2N8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de Réadaptation Lucie-Bruneau', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1M 2S8', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Lee Kirby, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nova Scotia Health Authority'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nova Scotia Health Authority', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Staff Physician, Department of Medicine', 'investigatorFullName': 'Lee Kirby', 'investigatorAffiliation': 'Nova Scotia Health Authority'}}}}