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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01432418
Other study ID # 230378
Secondary ID CDHA-RS/2012-133
Status Completed
Phase N/A
First received September 8, 2011
Last updated May 6, 2016
Start date June 2012
Est. completion date September 2014

Study information

Verified date May 2016
Source Nova Scotia Health Authority
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date September 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Wheelchair skills training program
A training program that uses methods based on the rehabilitation, wheelchair, and motor skills literature to teach wheelchair skills.

Locations

Country Name City State
Canada Nova Scotia Rehabilitation Centre Halifax Nova Scotia
Canada University of Western Ontario London Ontario
Canada Centre de Réadaptation Lucie-Bruneau Montreal Quebec
Canada Centre Interdisciplinaire de Recherche en Réadaptation et Intégration Sociale Quebec City Quebec
Canada Toronto Rehab Toronto Ontario
Canada GFS Rehabilitation Centre Vancouver British Columbia

Sponsors (2)

Lead Sponsor Collaborator
Nova Scotia Health Authority Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in Wheelchair Skills, WST 4.1 questionnaire version 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 Yes
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