Training to Enhance Adaptation and Management for Wheelchair Users (TEAMWheels)

NCT04090177 | Unknown

• 2 other identifiers: #50326/321741HS22711 (H2019:124)
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the effect of a 1-month, peer-led eHealth training program (TEAM Wheels) on satisfaction with activity participation and related rehabilitation outcomes among individuals transitioning to manual wheelchair use, compared with current wheelchair training practice. The primary objectives include: 1. Measuring the effect of TEAM Wheels on satisfaction with participation in important activities of life compared to current practice; 2. Measuring retention of participation benefits at 6-months post treatment. Secondary Objectives relate to additional rehabilitation Outcomes and include: 1. Comparing the effect of TEAM Wheels to current practice on wheelchair skills capacity and performance; wheelchair-specific self-efficacy; health-related quality of life; and objective measurement of wheelchair mobility. 2. Measuring retention of rehabilitation outcome benefits at 6-months post treatment.

Conditions

Mobility Limitation

Outcome Measures

Primary Outcomes (3)

• Satisfaction with Participation: Wheelchair Outcome Measure (WhOM)

  WhOM has been found to be the only tool that includes activities selected and weighted by the user and featured participation in social roles. WhOM has been identified as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. It is administered as a semi-structured interview. Respondents identify 10 activities (5 performed inside and 5 performed outside of the home), rating their satisfaction with performance on an 11-point scale (0-10) for each activity. The WhOM demonstrates good reliability (Test-retest ICC = 0.83-0.88; Inter-rater ICC = 0.90-0.91) and validity (correlations with LIFE-H: rs = 0.3-0.5) in use among individuals with spinal cord injury and older adults (Test-retest ICC = 0.77-1.00; correlation with QUEST rs = 0.36 -0.45).

  Baseline

• Satisfaction with Participation: Wheelchair Outcome Measure (WhOM)

  WhOM has been found to be the only tool that includes activities selected and weighted by the user and featured participation in social roles. WhOM has been identified as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. It is administered as a semi-structured interview. Respondents identify 10 activities (5 performed inside and 5 performed outside of the home), rating their satisfaction with performance on an 11-point scale (0-10) for each activity. The WhOM demonstrates good reliability (Test-retest ICC = 0.83-0.88; Inter-rater ICC = 0.90-0.91) and validity (correlations with LIFE-H: rs = 0.3-0.5) in use among individuals with spinal cord injury and older adults (Test-retest ICC = 0.77-1.00; correlation with QUEST rs = 0.36 -0.45).

  Post-Treatment (Week 7)

• Satisfaction with Participation: Wheelchair Outcome Measure (WhOM)

  WhOM has been found to be the only tool that includes activities selected and weighted by the user and featured participation in social roles. WhOM has been identified as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. It is administered as a semi-structured interview. Respondents identify 10 activities (5 performed inside and 5 performed outside of the home), rating their satisfaction with performance on an 11-point scale (0-10) for each activity. The WhOM demonstrates good reliability (Test-retest ICC = 0.83-0.88; Inter-rater ICC = 0.90-0.91) and validity (correlations with LIFE-H: rs = 0.3-0.5) in use among individuals with spinal cord injury and older adults (Test-retest ICC = 0.77-1.00; correlation with QUEST rs = 0.36 -0.45).

  6-Month Follow-up (Week 31)

Secondary Outcomes (12)

• Wheelchair Skills Test - Questionnaire (WST-Q)

  Baseline

• Wheelchair Skills Test - Questionnaire (WST-Q)

  Post-Treatment (Week 7)

• Wheelchair Skills Test - Questionnaire (WST-Q)

  6-Month Follow-up (Week 31)

• Wheelchair Use Confidence Scale-(WheelCon-SF)

  Baseline

• Wheelchair Use Confidence Scale-(WheelCon-SF)

  Post-Treatment (Week 7)

Other Outcomes (1)

• Cost

  Post-treatment (Week 7)

Study Arms (2)

Intervention-TEAM Wheels

EXPERIMENTAL

The treatment group will receive the TEAM Wheels program over a 4-week period. Session 1 will be virtually delivered via MS Teams teleconference. The peer trainer is an experienced MWC user trained to deliver the TEAM Wheels program. At least 2 peers will be trained at each site to offer multiple trainer attributes; a male and female, one being at least 50 years old. Participants will pre-select a peer trainer from a biosketch to optimize training effect (e.g., preference for age, sex factors); comparability in age has been identified as preferential among older adults and influential to self-efficacy. After Session 1, participants engage in 4 weeks of eHealth home program training. They are instructed to practice for 75-150 minutes/week. Consistent with motor learning principles, we encourage training in 15-30 minute blocks 1-2 times/day, 3-5 days/week. The peer trainer arranges the remaining two virtual teleconference sessions with the participant, about 1 week apart.

Behavioral: TEAM Wheels

Control-Wait List

NO INTERVENTION

The control group receives no specific intervention over the course of the 4-week period. This reflects "usual practice"/typical experience of a MWC user in their provincial context. Control group participants placed on the wait-list will receive the TEAM Wheels program following completion of the study (i.e. after post-treatment data collection). The site Research Coordinator/Assistant will make telephone or email contact with control group participants at the end of weeks 2 and 4 during the study period to deter attrition/drop-out. When contact is made at week 4, the Research Coordinator will schedule an appointment for post-treatment data collection (week 7). Any formal MWC training received during the wait-list period will be documented for potential post-hoc analysis as a confounding variable; research evidence and investigators' clinical experience confirm that in all 3 provinces formal training is not provided once MWC users are discharged from hospital.

Interventions

TEAM Wheels BEHAVIORAL

A 1-month, peer-led, eHealth training program (TEAM Wheels) for individuals transitioning to manual wheelchair use to improve satisfaction with activity participation and related rehabilitation outcomes.

Intervention-TEAM Wheels

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• use a MWC (even part time)
• living in the community
• have the ability to propel with both arms
• have sufficient language abilities to engage with the training material in English,

You may not qualify if:

• have a health condition that might interfere with training (e.g., cancer; surgery)
• concurrently receiving any MWC skills training beyond that of typical practice

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laval University: collaborator
• University of British Columbia: collaborator

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

RECRUITING

Universite Laval

Québec, G1M 2S8, Canada

RECRUITING

Related Publications (74)

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• Giesbrecht E, Best KL, Miller WC, Routhier F, Harrison KL, Faieta J, Laberge M. Effect of a Community-Based Peer-Led eHealth Wheelchair Skills Training Program: A Randomized Control Trial. Arch Phys Med Rehabil. 2025 Jun;106(6):821-827. doi: 10.1016/j.apmr.2024.12.011. Epub 2024 Dec 19.

  PMID: 39709023 DERIVED

Related Links

• Dalhousie University. Wheelchair Specifications Form

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ed Giesbrecht, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ed Giesbrecht, PhD

CONTACT

204-977-5630; Ed.Giesbrecht@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the investigators nor the biostatistician/outcomes assessor will know the intervention arm to which study participants have been assigned. A unique study ID will be assigned to each study participant and as well as a unique code to distinguish which intervention arm to which each participant is randomized.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The treatment group receives the TEAM Wheels program over a 4-week period. Three virtual/teleconference (MS Teams) sessions will be arranged between the peer-trainer and participant, about 1 week apart. Peer trainers are experienced MWC users trained to deliver the TEAM Wheels program. After Session 1, participants engage in 4 weeks of eHealth home program training. They are asked to practice for 75-150 minutes per week, in 15-30 minute blocks, 1-2 times/day, 3-5 days/week. The control group receives no intervention over the 4-wk period ("usual practice"). Control group participants placed on the wait-list will receive the TEAM Wheels program following completion of the study. Any formal MWC training received during the wait-list period will be documented for potential post-hoc analysis as a confounding variable; research evidence and clinical experience confirm that in all 3 provinces formal training is not provided once MWC users are discharged from hospital.

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: June 1, 2021
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available starting six months after publication of study findings in a peer reviewed journal.
• Access Criteria: Data access requests will be reviewed by the appropriate review panel. Requestors will be required to sign a Data Access/Sharing Agreement.

Locations

CA (3)