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Training to Enhance Adaptation and Management for Wheelchair Users (TEAM Wheels)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090177
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Laval University
University of British Columbia
Information provided by (Responsible Party):
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Behavioral: TEAM Wheels Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The treatment group receives the TEAM Wheels program over a 4-week period. Three in-person sessions will be arranged at the participant's home or community setting, 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Health Services Research
Official Title: Evaluation of a Peer-led eHealth Wheelchair Skills Training Program: Training to Enhance Adaptation and Management for Wheelchair Users
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

Arm Intervention/treatment
Experimental: Intervention-TEAM Wheels
The treatment group will receive the TEAM Wheels program over a 4-week period. An initial meeting (Session 1) will be arranged at the participant's home or community setting. The peer trainer is an experienced MWC user trained to deliver the TEAM Wheels program. At least 2 peers will 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 in-person sessions with the participant, about 1 week apart.
Behavioral: TEAM Wheels
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.

No Intervention: Control-Wait List
The control group receives no specific intervention over the course of the 4-week period. This reflects "usual practice" or the typical experience of a MWC user in their provincial context. Control group participants placed on the wait-list will receive the TEAM Wheels program, as described, following completion of the study (i.e. after post-treatment data collection). The site Research 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 Assistant 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; however, research evidence and the investigators' clinical experience confirm that in all 3 provinces formal training is not provided once MWC users are discharged from hospital.



Primary Outcome Measures :
  1. Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) [ Time Frame: Baseline ]
    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).

  2. Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) [ Time Frame: Post-Treatment (Week 7) ]
    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).

  3. Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) [ Time Frame: 6-Month Follow-up (Week 31) ]
    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).


Secondary Outcome Measures :
  1. Wheelchair Skills Test - Questionnaire (WST-Q) [ Time Frame: Baseline ]
    To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration.

  2. Wheelchair Skills Test - Questionnaire (WST-Q) [ Time Frame: Post-Treatment (Week 7) ]
    To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration.

  3. Wheelchair Skills Test - Questionnaire (WST-Q) [ Time Frame: 6-Month Follow-up (Week 31) ]
    To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration.

  4. Wheelchair Use Confidence Scale-(WheelCon-SF) [ Time Frame: Baseline ]
    Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 ("not confident") to 10 ("completely confident"), providing a total mean score (0-10).27 The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95).

  5. Wheelchair Use Confidence Scale-(WheelCon-SF) [ Time Frame: Post-Treatment (Week 7) ]
    Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 ("not confident") to 10 ("completely confident"), providing a total mean score (0-10).27 The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95).

  6. Wheelchair Use Confidence Scale-(WheelCon-SF) [ Time Frame: 6-Month Follow-up (Week 31) ]
    Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 ("not confident") to 10 ("completely confident"), providing a total mean score (0-10).27 The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95).

  7. Health Utilities Index Mark 3 (HUI3) [ Time Frame: Baseline ]
    Health utility measurement is useful when evaluating the impact of rehabilitation interventions. National guidelines for healthcare economic analyses strongly advocate the use of a validated measure of health-related quality of life (HRQL), which can be converted to quality-adjusted life years (QALY). HUI3 is a brief questionnaire that asks subjects about their health status. The multiple-attribute utility scale is scored from -0.36 to 1.00, with higher scores, reflected better health and quality of life. Acceptable test-retest reliability was found among patients recovering from hip fracture (ICC = 0.72) .

  8. Health Utilities Index Mark 3 (HUI3) [ Time Frame: Post-Treatment (Week 7) ]
    Health utility measurement is useful when evaluating the impact of rehabilitation interventions. National guidelines for healthcare economic analyses strongly advocate the use of a validated measure of health-related quality of life (HRQL), which can be converted to quality-adjusted life years (QALY). HUI3 is a brief questionnaire that asks subjects about their health status. The multiple-attribute utility scale is scored from -0.36 to 1.00, with higher scores, reflected better health and quality of life. Acceptable test-retest reliability was found among patients recovering from hip fracture (ICC = 0.72) .

  9. Health Utilities Index Mark 3 (HUI3) [ Time Frame: 6-Month Follow-up (Week 31) ]
    Health utility measurement is useful when evaluating the impact of rehabilitation interventions. National guidelines for healthcare economic analyses strongly advocate the use of a validated measure of health-related quality of life (HRQL), which can be converted to quality-adjusted life years (QALY). HUI3 is a brief questionnaire that asks subjects about their health status. The multiple-attribute utility scale is scored from -0.36 to 1.00, with higher scores, reflected better health and quality of life. Acceptable test-retest reliability was found among patients recovering from hip fracture (ICC = 0.72) .

  10. Objective Wheelchair Mobility [ Time Frame: Baseline ]
    To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation.

  11. Objective Wheelchair Mobility [ Time Frame: 2-weeks ]
    To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation.

  12. Objective Wheelchair Mobility [ Time Frame: 6-Month Follow-up ]
    To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age and older
  • within 12 months of receiving their first MWC
  • living in the community
  • have the ability to propel with both arms
  • have sufficient language abilities to engage with the training material in English,

Exclusion Criteria:

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

Information from the National Library of Medicine

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): NCT04090177


Contacts
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Contact: Ed Giesbrecht, PhD 204-977-5630 Ed.Giesbrecht@umanitoba.ca
Contact: Kathleen Clouston, PhD, MSc 204-787-8015 Kathleen.ChambersClouston@umanitoba.ca

Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 2G9
Contact: William C Miller, PhD, MSc (OT), BSc (OT), FCAOT    604-714-4108    bill.miller@ubc.ca   
Principal Investigator: William C Miller, PhD, MSc (OT), BSc (OT), FCAOT         
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0T6
Canada
Universite Laval
Québec, Canada, G1M 2S8
Contact: François Routhier, PhD    418-529-9141 ext 6256    francois.routhier@rea.ulaval.ca   
Contact: Krista L Best, PhD    418-529-9141 ext 6041    krista-lynn.best.1@ulaval.ca   
Sub-Investigator: Krista L Best, PhD         
Sub-Investigator: François Routhier, PhD         
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Laval University
University of British Columbia
Investigators
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Principal Investigator: Ed Giesbrecht, PhD University of Manitoba
Additional Information:
Publications:
Kirby RL. Wheelchair skills assessment and training. Boca Raton, FL: CRC Press, Taylor & Francis Group, 2017.
Bratter B and Freeman E. The maturing of peer counselling. Generations 1990; 14: 49-52
Bandura A. Self-efficacy: the exercise of control. New York: W. H. Freeman and Company, 1997.
Wilson P, Rodgers W, Blanchard C, et al. The relationship between psychological needs, self-determined motivation, exercise attitudes and physical fitness. Journal of Applied Social Psychology 2003; 33: 2373-2392.
Atkinson M. eHealth in Canada: current trends and future challenges. Ottawa: Information and Communications Technology Council, 2009.
Ding D, Cooper RA and Pearlman J. Incorporating participatory action design into research and education. In: International Conference on Engineering Education Coimbra, Portugal, 2007.
Gomes R, Michaelsen S, Rodrigues L, et al. Scientific research with individual post stroke: difficulties in recruitment, allocation and adherence on two different protocols of physiotherapy intervention. Fisioterapia e Pesquisa 2015; 22: 34-40. DOI: 10.590/1809-2950/13111022012015.
Best KL, Routhier F and Miller WC. Older adults' perceptions and experiences with a peer-led wheelchair training program. 34th International Seating Symposium. Vancouver, BC, 2018.
World Health Organization. International classification of functioning disability and health. Geneva: World Health Organization, 2001.
Talo C, Mannarini T and Rochira A. Sense of community and community participation: A meta-analytic review. Social Indicators Research 2014; 117: 1-28. DOI: 10.1007/s11205-013-0347-2.
Kenny S and Gowran RJ. Outcome Measures for Wheelchair and Seating Provision: A Critical Appraisal. British Journal of Occupational Therapy 2014; 77: 67-77. DOI: 10.4276/030802214x13916969447119.
Tabachnick BG and Fidell LS. Using multivariate statistics. 5th ed. Boston: Pearson Education, 2007.

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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04090177    
Other Study ID Numbers: #50326/321741
HS22711 (H2019:124) ( Other Identifier: University of Manitoba Health Research Ethics Board )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Specific individual participant data sets to be shared include all collected IPD.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms