WheelSee Feasibility Study
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|ClinicalTrials.gov Identifier: NCT01837888|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : May 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Self-efficacy||Device: WheelSee Training Program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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 Start Date :||November 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||August 2014|
No Intervention: Standard training provided by clinician
Participants in the control group will receive the current standard of care. (i.e., any training provided by the clinician or vendor who prescribes/provides the wheelchair). Participants will receive one follow up phone call to remind them of followup testing.
Experimental: WheelSee Training Program
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.
Device: WheelSee Training Program
WheelSee sessions will be administered by a peer-trainer, who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSee session will be tailored to the individual goals of participants, which will be identified during the start of each WheelSee session.
- Wheelchair-use Confidence Scale (WheelCon) Version 3.0 Change [ Time Frame: Baseline; 5 weeks ]Wheelchair-use Confidence Scale (WheelCon) Version 3.0 for manual wheelchair users is a 65-item self-report scale (0-100) with documented reliability and validity. Responses indicate current level of perceived confidence (%) to navigate the physical environment in a wheelchair, perform activities in a wheelchair, problem solve, advocate for specific needs, and manage social situations and emotions. The WheelCon was selected as the primary outcome measure because it is a standardized tool for evaluating confidence using a wheelchair, the primary construct of interest.
- Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q) [ Time Frame: Baseline; 5 weeks ]Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q) for manual wheelchair users is a standardized subjective evaluation of ability to execute 32 manual wheelchair skills (pass/fail) and the safety of skill execution (safe/unsafe). Total percent scores (0-100%) are calculated for both skill execution and safety.The WST was selected as a secondary measure because it measures wheelchair skills capacity and safety, both of which may influence or be influenced by confidence using a wheelchair.
- Life-Space Assessment (LSA) [ Time Frame: Baseline; 5 weeks ]Life-Space Assessment (LSA) is a 20-item questionnaire that tracks the mobility habits of wheelchair users in a continuum of environmental contexts (home; around the home; in the neighbourhood; in town; and outside of town). Participants report on their attainment of each life-space during the past 4 weeks, the frequency of attainment, and whether assistance was required. The LSA was selected as an outcome measure because it provides information about an individual's mobility habits.
- The Wheelchair Outcome Measure (WhOM) [ Time Frame: Baseline; 5 weeks ]The Wheelchair Outcome Measure (WhOM) is a client-specific measurement tool that identifies satisfaction with participation in desired activities for wheelchair users. Rates of perceived 'importance' of the goal (0-10) and 'satisfaction' with current performance of this activity (0-10) will be obtained. Scoring is calculated by multiplying 'importance' by 'satisfaction'. The WhOM was selected to obtain some information about participation goals of manual wheelchair users and to explore whether a wheelchair training intervention could influence perceived satisfaction with participation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837888
|Canada, British Columbia|
|GF Strong Rehabilitation Centre|
|Vancouver, British Columbia, Canada, V5Z 2G9|
|Principal Investigator:||William C Miller, PhD||University of British Columbia|