WheelSee Feasibility Study

NCT ID: NCT01837888

Last Updated: 2018-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2014-08-31

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.

Conditions

Self-efficacy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

WheelSee Training Program

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

William C. Miller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

William C Miller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

GF Strong Rehabilitation Centre

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26343171 (View on PubMed)

Other Identifiers

H11-02687

Identifier Type: -

Identifier Source: org_study_id