NCT01838135

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 for older adults (WheelSeeU) to determine if: 1.WheelSeeU is feasible to administer; 2. WheelSeeU improves wheelchair use, confidence for wheelchair use, wheelchair mobility, and satisfaction with participation in older adults compared to group-based information sessions; and 3. the study design is appropriate. 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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 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

March 1, 2013

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2013

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

March 28, 2013

Last Update Submit

July 25, 2024

Conditions

Keywords

wheelchairmanual wheelchairrehabilitationself-efficacyolder adultsfeasibilityinterventiontraining

Outcome Measures

Primary Outcomes (1)

  • Wheelchair Skills Test Version 4.1 (WST) Change

    Wheelchair Skills Test Version 4.1 (WST) for manual wheelchair users is a standardized objective evaluation of the execution of 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 the primary measure because it is a standardized tool for evaluating wheelchair capacity, the primary construct of interest.

    Baseline, 6 weeks, 6 month follow-up

Secondary Outcomes (6)

  • Wheelchair-use Confidence Scale (WheelCon) Version 3.0

    Baseline, 6 weeks, 6 month follow-up

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

    Baseline, 6 weeks, 6 month follow-up

  • Life-Space Assessment (LSA)

    Baseline, 6 weeks, 6 month follow-up

  • Wheelchair Outcome Measure (WhOM)

    Baseline, 6 weeks, 6 month follow-up

  • Late Life Function and Disability Instrument (LLFDI)

    Baseline, 6 weeks, 6 month follow-up

  • +1 more secondary outcomes

Study Arms (2)

Group-based information sessions

NO INTERVENTION

Control group subjects will take part in 6 x 1.5 hour sessions of group-based information sessions facilitated by a trained instructor, consisting of topics on general wheelchair use, transportation, pain and fatigue management, nutrition, and internet resources. The instructor will be trained to not provide any training on wheelchair skills, and will be instructed to divert any wheelchair skills related questions.

WheelSeeU Training Program

EXPERIMENTAL

Experimental group subjects will attend 6 x 1.5 hour training sessions (1-2 sessions/week) with a peer-Trainer. The peer-Trainer will facilitate WheelSeeU sessions and will lead participants through practice of wheelchair use goals.

Device: WheelSeeU Training Program

Interventions

WheelSeeU sessions will be administered by a peer-trainer (older adult wheelchair user), 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 WheelSeeU session will be tailored to the individual goals of participants, which will be identified during the start of each session.

WheelSeeU Training Program

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • live in the community
  • self-propel a manual wheelchair at least 1 hour/day
  • have wheelchair mobility goals
  • are cognitively able to engage in the program (Modified Mini-mental Status Exam score of ≥ 24).

You may not qualify if:

  • cannot communicate and complete study questionnaires in English
  • anticipate a health condition or procedure that contraindicates training (e.g., surgery scheduled which would impair physical activity)
  • have a degenerative condition that is expected to progress quickly (e.g., Amyotrophic lateral sclerosis (ALS))
  • are concurrently or are planning to receive wheelchair mobility training during the period of the study.

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 (3)

  • Miller WC, Best KL, Eng JJ, Routhier F. Influence of Peer-led Wheelchair Training on Wheelchair Skills and Participation in Older Adults: Clinical Outcomes of a Randomized Controlled Feasibility Trial. Arch Phys Med Rehabil. 2019 Jun;100(6):1023-1031. doi: 10.1016/j.apmr.2018.10.018. Epub 2018 Nov 23.

  • Best KL, Miller WC, Routhier F, Eng JJ. Feasibility of the trial procedures for a randomized controlled trial of a community-based peer-led wheelchair training program for older adults. Pilot Feasibility Stud. 2017 Jul 17;4:18. doi: 10.1186/s40814-017-0158-3. eCollection 2018.

  • Best KL, Miller WC, Eng JJ, Routhier F, Goldsmith C. Randomized controlled trial protocol feasibility: The Wheelchair Self-Efficacy Enhanced for Use (WheelSeeU). Can J Occup Ther. 2014 Dec;81(5):308-19. doi: 10.1177/0008417414546743.

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

March 28, 2013

First Posted

April 23, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2016

Study Completion

October 1, 2016

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations