Clinical trial NCT01837888: WheelSee Feasibility Study
Official title: A Feasibility Study to Evaluate and Refine a Manual Wheelchair Training Program That is Enhanced for Self-efficacy(WheelSee): A Pilot Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self-efficacy
Keywords: wheelchair
manual wheelchair
rehabilitation
self-efficacy
older adults
feasibility
intervention
training
Wheelchair mobility
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2013-04-23
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Self-efficacy predicts behavioural and rehabilitation outcomes and may be an important psychological factor for wheelchair mobility. A feasibility study will evaluate a novel self-efficacy enhanced wheelchair training intervention (WheelSee) to determine if: 1.WheelSee improves self-efficacy compared to standard care; 2. study design is appropriate; and 3. The WheelSee intervention protocol is suitable. This feasibility study will allow for study design and protocol refinement and will provide pilot data for an experimental trial.

Detailed description: The purpose of this study is to evaluate the feasibility of administering a novel self-efficacy enhanced wheelchair training intervention (WheelSee) for manual wheelchair users who are at least 19 years of age. Self-efficacy for wheelchair use is an important construct, which may influence wheelchair mobility and participation. Pilot data obtained from this study will inform the design of an experimental trial and refinement of the WheelSee intervention and protocol.

This study will use a randomized controlled, single blind design with a sample of 24 (12 intervention, 12 control). Participants will be randomly allocated to the intervention or control group using a computer generated table of random numbers. Participants allocated to the intervention group will take part in WheelSee in groups of 2-4. The WheelSee intervention consists of 6 (twice weekly, minimum 3 days apart) x 1.5 hour sessions. Participants will be encouraged to bring a family member to each session, who may act as a spotter during the practice of wheelchair skills. If no family member is available, a student volunteer spotter will be available to ensure a 1:1 spotter: wheelchair user ratio. All spotters will be trained in appropriate spotting techniques.

Eligibility criteria: Inclusion Criteria:

* 19 years of age or older
* Reside in the community
* Daily use of a manual wheelchair (≥ 2 hours/day)
* Able to self-propel (using any combination of hands or feet) a distance of 10 m
* Would like to improve confidence using a manual wheelchair
* Have wheelchair mobility goals
* Able to read, write and speak at a Grade 8 English level
* Score 25 or higher on the Mini Mental State Examination (MMSE)

Exclusion Criteria:

* Have previously or are currently taking part in standardized wheelchair training
* Are acutely ill

Primary outcomes:
measure: Wheelchair-use Confidence Scale (WheelCon) Version 3.0 Change
timeFrame: Baseline; 5 weeks
Secondary outcomes:
measure: Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q)
timeFrame: Baseline; 5 weeks
measure: Life-Space Assessment (LSA)
timeFrame: Baseline; 5 weeks
measure: The Wheelchair Outcome Measure (WhOM)
timeFrame: Baseline; 5 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: GF Strong Rehabilitation Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: William C Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Best KL, Miller WC, Huston G, Routhier F, Eng JJ. Pilot Study of a Peer-Led Wheelchair Training Program to Improve Self-Efficacy Using a Manual Wheelchair: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2016 Jan;97(1):37-44. doi: 10.1016/j.apmr.2015.08.425. Epub 2015 Sep 4.