- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01432418
Effectiveness of a Wheelchair Skills Training Program for Power Mobility Users: A Randomized Controlled Trial
May 6, 2016 updated by: Lee Kirby, Nova Scotia Health Authority
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 2G9
- GFS Rehabilitation Centre
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3H 4K4
- Nova Scotia Rehabilitation Centre
-
-
Ontario
-
London, Ontario, Canada, N6G 1H1
- University of Western Ontario
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Toronto, Ontario, Canada, M5G 1V7
- Toronto Rehab
-
-
Quebec
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Montreal, Quebec, Canada, H2H 2N8
- Centre de Réadaptation Lucie-Bruneau
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Quebec City, Quebec, Canada, G1M 2S8
- Centre interdisciplinaire de recherche en réadaptation et intégration sociale
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- new or experienced powered wheelchair users
- use or are expected to use powered wheelchairs for at least 4 hrs/week
- 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
- equal or greater than 18 years of age
- able to follow directions in either French or English (whichever is in use at the participating site)
- have the potential to operate their powered wheelchairs independently
- have room for improvement (in the opinion of the potential participant's clinician)
- requires no more than minimal assistance for communication and auditory comprehension (in the opinion of the potential participant's clinician)
- able to follow 2-step commands
- demonstrate the ability to attend training sessions during the intake session
- competent to provide their own informed consent
- able to be comfortably seated in the powered wheelchairs that will be used for the study (if not their own).
Exclusion Criteria:
- use or are expected to use a scooter
- have a rapidly progressive disorder (e.g. amyotrophic lateral sclerosis or terminal cancer)
- have significant visual impairments (legally blind)
- have unstable medical conditions (e.g. angina, seizures)
- have emotional problems (e.g. severe anxiety, depression) that might make participation unsafe or unpleasant
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: wheelchair training
|
A training program that uses methods based on the rehabilitation, wheelchair, and motor skills literature to teach wheelchair skills.
|
|
NO_INTERVENTION: Control
Standard of care only
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Wheelchair Skills, WST 4.1 questionnaire version
Time Frame: baseline, 1 month , 3 months
|
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.
|
baseline, 1 month , 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lee Kirby, MD, FRCP, Nova Scotia Health Authority
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (ACTUAL)
September 1, 2014
Study Completion (ACTUAL)
September 1, 2014
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 9, 2011
First Posted (ESTIMATE)
September 13, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 9, 2016
Last Update Submitted That Met QC Criteria
May 6, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 230378
- CDHA-RS/2012-133 (OTHER: Capital Health Ethics Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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