NCT01837888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

April 18, 2013

Last Update Submit

May 25, 2018

Conditions

Keywords

wheelchairmanual wheelchairrehabilitationself-efficacyolder adultsfeasibilityinterventiontrainingWheelchair mobility

Outcome Measures

Primary Outcomes (1)

  • Wheelchair-use Confidence Scale (WheelCon) Version 3.0 Change

    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.

    Baseline; 5 weeks

Secondary Outcomes (3)

  • Wheelchair Skills Test Version 4.1 Questionnaire (WST-Q)

    Baseline; 5 weeks

  • Life-Space Assessment (LSA)

    Baseline; 5 weeks

  • The Wheelchair Outcome Measure (WhOM)

    Baseline; 5 weeks

Study Arms (2)

Standard training provided by clinician

NO INTERVENTION

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.

WheelSee Training Program

EXPERIMENTAL

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

Interventions

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.

WheelSee Training Program

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

Location

Related Publications (1)

  • 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.

Study Officials

  • William C Miller, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 18, 2013

First Posted

April 23, 2013

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2014

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations