Mobility LimitationTEAMWheelsNCT04090177
Training to Enhance Adaptation and Management for Wheelchair Users (TEAMWheels)
A study testing TEAM Wheels in people with Mobility Limitation, run by University of Manitoba at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- TEAM Wheels
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jun 2021to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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,
Who cannot join
- have a health condition that might interfere with training (e.g., cancer; surgery)
- concurrently receiving any MWC skills training beyond that of typical practice
Trial locations and contacts
3 sites in 1 country.
Canada3 sites, 3 recruiting
- Recruiting
Universite Laval
Québec, G1M 2S8
François Routhier, PhD, 418-529-9141 ext. 6256, francois.routhier@rea.ulaval.ca
Krista L Best, PhD, 418-529-9141 ext. 6041, krista-lynn.best.1@ulaval.ca
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z 2G9
William C Miller, PhD, MSc OT, 604-714-4108, bill.miller@ubc.ca
William C Miller, PhD, MSc OT
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 0T6
Ed M Giesbrecht, PhD (Cand.), 204-977-5630, Ed.Giesbrecht@med.umanitoba.ca
Ed M Giesbrecht, PhD (Cand.)
About this study
Official title: Evaluation of a Peer-led eHealth Wheelchair Skills Training Program: Training to Enhance Adaptation and Management for Wheelchair Users
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.
Read the detailed description
This study will use a three-site (Winnipeg, Vancouver, and Quebec City) randomized controlled trial to compare differences in current wheelchair training practice and a 1-month, peer-led (virtual due to SARS-CoV-2; COVID-19) eHealth training program (TEAM Wheels). Subjects will randomly be assigned to the TEAM Wheels or control group using a 1:1 allocation ratio between groups. To support balance between groups and masking of assignment, our statistician will create a computerized randomization process with undisclosed block size. Once subjects are enrolled, baseline data will be collected and entered into a secure database. A site coordinator or assistant will then obtain the participant's group assignment and coordinate the first in-person peer trainer session. For treatment group assignments this will occur as soon as it is practical and for control group assignments this will be scheduled after blinded post-treatment data collection is complete. To address bias, subjects will be instructed not to discuss their program.
The treatment group will receive the TEAM Wheels program over a 4-week period. An initial meeting (Session 1) will be arranged via teleconference (MS Teams). The peer trainer is an experienced Manual Wheelchair (MWC) user trained to deliver the TEAM Wheels program. At least 2 peers will be hired and trained at each site to offer multiple trainer attributes. We will intentionally include a male and female, one being at least 50 years of age. Participants will pre-select a peer trainer based on 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. Following Session 1, participants engage in 4 weeks of training with the eHealth home program. They are instructed to practice for 75 to 150 minutes per week. Consistent with motor learning principles, we encourage training in 15-30 minute blocks 1-2 times per day, 3-5 days per week. The peer trainer will arrange with the participant the remaining two virtual sessions, approximately one week apart.
Control Group. 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 Coordinator 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 Coordinatort 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.
Assessments. The outcome measures will be collected at baseline (pre-randomization) and post-intervention. A Research Assistant/Coordinator at each site will contact the participant via MS Teams videoconference at baseline and subsequent data collection points to administer the outcome measures. Participants will be shown a video to help them apply an Actigraph device (i.e. small battery-operated accelerometer) to the participant's wheelchair spokes and after 2 weeks will either retrieve it or provide a self-addressed stamped envelope for the participant to return via post. Post-treatment data will be collected at week 7 to incorporate a 2-week window for consolidation of learning following the 4-week intervention. Follow-up (retention) data will be collected from treatment group participants 6 months later (week 31).
Outcome measures. At baseline, descriptive characteristics including age, sex, gender, marital status, the highest level of education, primary diagnoses related to MWC use, Wheel diameter, and length of time using the MWC will be collected. Five outcome measures will be administered at baseline, post-treatment, and 6-month follow-up (for treatment group participants).
Wheelchair Skills Test - Questionnaire (WST-Q). 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.
Wheelchair Outcome Measure (WhOM). The rehabilitation literature strongly suggests that intervention outcomes should include not only externally defined measures but also measures of user-identified activities of relevance and perceived satisfaction with performance. A 2008 review of wheelchair-specific outcomes found the WhOM was the only tool that included activities selected and weighted by the user and featured participation in social roles.Two published literature reviews identify the WhOM as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. WhOM 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).
Wheelchair Use Confidence Scale-(WheelCon-SF). 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). 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).
The Short-Form 36 (SF-36) Health Survey Questionnaire is a measure of health status across the following domains: physical function, physical limitations, emotional limitations, pain, social function, energy, perceived health, and mental health. The literature identifies inherent wording bias of the mobility-related SF-36 test items, which presume ambulation as a norm so we opted to use the Enabled version that explicitly acknowledges the use of a mobility aid and replaces the words "climbing" and "walking" with "going". Short Form-36E (Enabled) is specific to the study population of manual wheelchair users and will provide detailed and specific data related to HRQL.
Objective Wheelchair Mobility. 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.
Program details TEAM Wheels is a 4-week, community-based, tailored program integrating eHealth and peer-led components to optimize learning while limiting the time demands of health care professionals. The eHealth component is a 10" computer tablet with a custom training application. The tablet mounts conveniently on the lap for "in-chair" training, enabling MWC users to learn and practice mobility skills in authentic contexts of home and community. The interactive application includes a structured curriculum with over 200 video clips featuring education, peer demonstration, and training activities. The peer-led component involves experienced MWC users with specialized training who can leverage their own experience and ability to relate as influential peers. The peer trainer conducts 3 virtual/teleconference (MS Teams) sessions with the participant, negotiating individualized goals, introducing wheelchair skills and management strategies, and providing an orientation to the eHealth home program. Peer trainers monitor eHealth training activity, which the tablet uploads to a secure website, intervening or modifying the program when required. Additional communication can be initiated between MWC user and peer trainer using a video messaging through MS Teams (on the computer tablet). The tablet is menu driven and interactive, using a touch-screen interface. A tablet offers considerable advantages over traditional paper/hand-out home programs. Training is provided in a multi-modal format with illustrations and videos, allowing detailed step-by-step guidance, close-ups, and demonstrations using age-appropriate older adult models. Practice activities can be clearly demonstrated (to ensure they are performed appropriately) and include imitative, function-based, and interactive game-related activities. Subjects can also contact their Peer-Trainer using the MS Teams (on the tablet); Trainers will review and respond within 48 hours. The tablet is housed in a rigid case with a simple strap that wraps around the participant's thighs. Subjects can secure the tablet on their lap and practice anywhere in their home or community, or place the tablet on another surface for viewing or video recording. Training activities are highlighted/checked off after completion, indicating to the subject they can advance to the next component. A "Progress" tab provides regular updates on the number of minutes practiced each week to reinforce adherence. The tablet will have Internet access for communication and data transfer/update capability, but the training program can operate in stand-alone mode as well.
- Conditions
- Mobility Limitation
- Being tested
- TEAM Wheels
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEAM WheelsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 6-Month Follow-up (Week 31)
Secondary outcomes (12)
Wheelchair Skills Test - Questionnaire (WST-Q)
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.
Measured: Baseline
Wheelchair Skills Test - Questionnaire (WST-Q)
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.
Measured: Post-Treatment (Week 7)
Wheelchair Skills Test - Questionnaire (WST-Q)
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.
Measured: 6-Month Follow-up (Week 31)
Wheelchair Use Confidence Scale-(WheelCon-SF)
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).
Measured: Baseline
Wheelchair Use Confidence Scale-(WheelCon-SF)
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).
Measured: Post-Treatment (Week 7)
Wheelchair Use Confidence Scale-(WheelCon-SF)
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).
Measured: 6-Month Follow-up (Week 31)
Short Form-36E (Enabled)
Full title: Short Form 36 Health Survey Questionnaire (SF-36) (Enabled) 'Enabled' indicates wording is included above terms requiring adaptation for individuals requiring mobility assistive devices (the word "go" replaces "walk" and "climb").
SF-36E is a questionnaire specific to the study population of manual wheelchair users that provides detailed data related to HRQL specific to this population, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Measured: Baseline
Short Form-36E (Enabled)
Full title: Short Form 36 Health Survey Questionnaire (SF-36) (Enabled) 'Enabled' indicates wording is included above terms requiring adaptation for individuals requiring mobility assistive devices (the word "go" replaces "walk" and "climb").
SF-36E is a questionnaire specific to the study population of manual wheelchair users that provides detailed data related to HRQL specific to this population, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Measured: Post-Treatment (Week 7)
Short Form-36E (Enabled)
Full title: Short Form 36 Health Survey Questionnaire (SF-36) (Enabled) 'Enabled' indicates wording is included above terms requiring adaptation for individuals requiring mobility assistive devices (the word "go" replaces "walk" and "climb").
SF-36E is a questionnaire specific to the study population of manual wheelchair users that provides detailed data related to HRQL specific to this population, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health.
Measured: 6-Month Follow-up (Week 31)
Objective Wheelchair Mobility
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.
Measured: Baseline
Objective Wheelchair Mobility
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.
Measured: 2-weeks
Objective Wheelchair Mobility
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.
Measured: 6-Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start1 Jun 2021
- Primary completionApr 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (75)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Laval University, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Ed Giesbrecht, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090177
- Sponsor's protocol ID
- #50326/321741
- Other IDs
- HS22711 (H2019:124)
- Acronym
- TEAMWheels
- Status last verified
- Nov 2023
- First submitted
- 11 Sep 2019
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Specific individual participant data sets to be shared include all collected IPD.
Publications
Giesbrecht EM, Miller WC. A randomized control trial feasibility evaluation of an mHealth intervention for wheelchair skill training among middle-aged and older adults. PeerJ. 2017 Oct 5;5:e3879. doi: 10.7717/peerj.3879. eCollection 2017.
PubMed 29018615Best 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.
PubMed 28725451Best 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.
PubMed 25702375Best 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.
PubMed 26343171Smith EM, Giesbrecht EM, Mortenson WB, Miller WC. Prevalence of Wheelchair and Scooter Use Among Community-Dwelling Canadians. Phys Ther. 2016 Aug;96(8):1135-42. doi: 10.2522/ptj.20150574. Epub 2016 Feb 4.
PubMed 26847009Giesbrecht EM, Smith EM, Mortenson WB, Miller WC. Needs for mobility devices, home modifications and personal assistance among Canadians with disabilities. Health Rep. 2017 Aug 16;28(8):9-15.
PubMed 29044443Shields M. Use of wheelchairs and other mobility support devices. Health Rep. 2004 May;15(3):37-41. No abstract available.
PubMed 15208888Finlayson M, van Denend T. Experiencing the loss of mobility: perspectives of older adults with MS. Disabil Rehabil. 2003 Oct 21;25(20):1168-80. doi: 10.1080/09638280310001596180.
PubMed 14534060Simpson RC, LoPresti EF, Cooper RA. How many people would benefit from a smart wheelchair? J Rehabil Res Dev. 2008;45(1):53-71. doi: 10.1682/jrrd.2007.01.0015.
PubMed 18566926Rudman DL, Hebert D, Reid D. Living in a restricted occupational world: the occupational experiences of stroke survivors who are wheelchair users and their caregivers. Can J Occup Ther. 2006 Jun;73(3):141-52. doi: 10.2182/cjot.05.0014.
PubMed 16871856Kirby RL, Ackroyd-Stolarz SA, Brown MG, Kirkland SA, MacLeod DA. Wheelchair-related accidents caused by tips and falls among noninstitutionalized users of manually propelled wheelchairs in Nova Scotia. Am J Phys Med Rehabil. 1994 Sep-Oct;73(5):319-30. doi: 10.1097/00002060-199409000-00004.
PubMed 7917161Gavin-Dreschnack D, Nelson A, Fitzgerald S, Harrow J, Sanchez-Anguiano A, Ahmed S, Powell-Cope G. Wheelchair-related falls: current evidence and directions for improved quality care. J Nurs Care Qual. 2005 Apr-Jun;20(2):119-27. doi: 10.1097/00001786-200504000-00006.
PubMed 15839290Tu CJ, Liu L, Wang W, Du HP, Wang YM, Xu YB, Li P. Effectiveness and safety of wheelchair skills training program in improving the wheelchair skills capacity: a systematic review. Clin Rehabil. 2017 Dec;31(12):1573-1582. doi: 10.1177/0269215517712043. Epub 2017 Jun 5.
PubMed 28580801Keeler L, Kirby RL, Parker K, McLean KD, Hayden JA. Effectiveness of the Wheelchair Skills Training Program: a systematic review and meta-analysis. Disabil Rehabil Assist Technol. 2019 May;14(4):391-409. doi: 10.1080/17483107.2018.1456566. Epub 2018 Apr 4.
PubMed 29616832MacPhee AH, Kirby RL, Coolen AL, Smith C, MacLeod DA, Dupuis DJ. Wheelchair skills training program: A randomized clinical trial of wheelchair users undergoing initial rehabilitation. Arch Phys Med Rehabil. 2004 Jan;85(1):41-50. doi: 10.1016/s0003-9993(03)00364-2.
PubMed 14970966
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Peer-led eHealth Wheelchair Skills Training Program: Training to Enhance Adaptation and Management for Wheelchair Users
- ClinicalTrials.gov ID
- NCT04090177
- Acronym / sponsor ID
- TEAMWheels / #50326/321741
- Conditions
- Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Laval University, University of British Columbia
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will use a three-site (Winnipeg, Vancouver, and Quebec City) randomized controlled trial to compare differences in current wheelchair training practice and a 1-month, peer-led (virtual due to SARS-CoV-2; COVID-19) eHealth training program (TEAM Wheels). Subjects will randomly be assigned to the TEAM Wheels or control group using a 1:1 allocation ratio between groups. To support balance between groups and masking of assignment, our statistician will create a computerized randomization process with undisclosed block size. Once subjects are enrolled, baseline data will be collected and entered into a secure database. A site coordinator or assistant will then obtain the participant's group assignment and coordinate the first in-person peer trainer session. For treatment group assignments this will occur as soon as it is practical and for control group assignments this will be scheduled after blinded post-treatment data collection is complete. To address bias, subjects will be instructed not to discuss their program.
The treatment group will receive the TEAM Wheels program over a 4-week period. An initial meeting (Session 1) will be arranged via teleconference (MS Teams). The peer trainer is an experienced Manual Wheelchair (MWC) user trained to deliver the TEAM Wheels program. At least 2 peers will be hired and trained at each site to offer multiple trainer attributes. We will intentionally include a male and female, one being at least 50 years of age. Participants will pre-select a peer trainer based on 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. Following Session 1, participants engage in 4 weeks of training with the eHealth home program. They are instructed to practice for 75 to 150 minutes per week. Consistent with motor learning principles, we encourage training in 15-30 minute blocks 1-2 times per day, 3-5 days per week. The peer trainer will arrange with the participant the remaining two virtual sessions, approximately one week apart.
Control Group. 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 Coordinator 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 Coordinatort 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.
Assessments. The outcome measures will be collected at baseline (pre-randomization) and post-intervention. A Research Assistant/Coordinator at each site will contact the participant via MS Teams videoconference at baseline and subsequent data collection points to administer the outcome measures. Participants will be shown a video to help them apply an Actigraph device (i.e. small battery-operated accelerometer) to the participant's wheelchair spokes and after 2 weeks will either retrieve it or provide a self-addressed stamped envelope for the participant to return via post. Post-treatment data will be collected at week 7 to incorporate a 2-week window for consolidation of learning following the 4-week intervention. Follow-up (retention) data will be collected from treatment group participants 6 months later (week 31).
Outcome measures. At baseline, descriptive characteristics including age, sex, gender, marital status, the highest level of education, primary diagnoses related to MWC use, Wheel diameter, and length of time using the MWC will be collected. Five outcome measures will be administered at baseline, post-treatment, and 6-month follow-up (for treatment group participants).
Wheelchair Skills Test - Questionnaire (WST-Q). 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.
Wheelchair Outcome Measure (WhOM). The rehabilitation literature strongly suggests that intervention outcomes should include not only externally defined measures but also measures of user-identified activities of relevance and perceived satisfaction with performance. A 2008 review of wheelchair-specific outcomes found the WhOM was the only tool that included activities selected and weighted by the user and featured participation in social roles.Two published literature reviews identify the WhOM as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. WhOM 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).
Wheelchair Use Confidence Scale-(WheelCon-SF). 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). 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).
The Short-Form 36 (SF-36) Health Survey Questionnaire is a measure of health status across the following domains: physical function, physical limitations, emotional limitations, pain, social function, energy, perceived health, and mental health. The literature identifies inherent wording bias of the mobility-related SF-36 test items, which presume ambulation as a norm so we opted to use the Enabled version that explicitly acknowledges the use of a mobility aid and replaces the words "climbing" and "walking" with "going". Short Form-36E (Enabled) is specific to the study population of manual wheelchair users and will provide detailed and specific data related to HRQL.
Objective Wheelchair Mobility. 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.
Program details TEAM Wheels is a 4-week, community-based, tailored program integrating eHealth and peer-led components to optimize learning while limiting the time demands of health care professionals. The eHealth component is a 10" computer tablet with a custom training application. The tablet mounts conveniently on the lap for "in-chair" training, enabling MWC users to learn and practice mobility skills in authentic contexts of home and community. The interactive application includes a structured curriculum with over 200 video clips featuring education, peer demonstration, and training activities. The peer-led component involves experienced MWC users with specialized training who can leverage their own experience and ability to relate as influential peers. The peer trainer conducts 3 virtual/teleconference (MS Teams) sessions with the participant, negotiating individualized goals, introducing wheelchair skills and management strategies, and providing an orientation to the eHealth home program. Peer trainers monitor eHealth training activity, which the tablet uploads to a secure website, intervening or modifying the program when required. Additional communication can be initiated between MWC user and peer trainer using a video messaging through MS Teams (on the computer tablet). The tablet is menu driven and interactive, using a touch-screen interface. A tablet offers considerable advantages over traditional paper/hand-out home programs. Training is provided in a multi-modal format with illustrations and videos, allowing detailed step-by-step guidance, close-ups, and demonstrations using age-appropriate older adult models. Practice activities can be clearly demonstrated (to ensure they are performed appropriately) and include imitative, function-based, and interactive game-related activities. Subjects can also contact their Peer-Trainer using the MS Teams (on the tablet); Trainers will review and respond within 48 hours. The tablet is housed in a rigid case with a simple strap that wraps around the participant's thighs. Subjects can secure the tablet on their lap and practice anywhere in their home or community, or place the tablet on another surface for viewing or video recording. Training activities are highlighted/checked off after completion, indicating to the subject they can advance to the next component. A "Progress" tab provides regular updates on the number of minutes practiced each week to reinforce adherence. The tablet will have Internet access for communication and data transfer/update capability, but the training program can operate in stand-alone mode as well.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention-TEAM Wheels | Experimental | Behavioral: TEAM WheelsThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 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,
Key exclusion criteria (2 listed)
- have a health condition that might interfere with training (e.g., cancer; surgery)
- concurrently receiving any MWC skills training beyond that of typical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEAM WheelsA 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. | Behavioural | Intervention-TEAM Wheels |
Primary outcome
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).
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).
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).
12 secondary outcomes
Wheelchair Skills Test - Questionnaire (WST-Q)
Time frame: Baseline
Wheelchair Skills Test - Questionnaire (WST-Q)
Time frame: Post-Treatment (Week 7)
Wheelchair Skills Test - Questionnaire (WST-Q)
Time frame: 6-Month Follow-up (Week 31)
Wheelchair Use Confidence Scale-(WheelCon-SF)
Time frame: Baseline
Wheelchair Use Confidence Scale-(WheelCon-SF)
Time frame: Post-Treatment (Week 7)
Wheelchair Use Confidence Scale-(WheelCon-SF)
Time frame: 6-Month Follow-up (Week 31)
Short Form-36E (Enabled)
Time frame: Baseline
Short Form-36E (Enabled)
Time frame: Post-Treatment (Week 7)
Short Form-36E (Enabled)
Time frame: 6-Month Follow-up (Week 31)
Objective Wheelchair Mobility
Time frame: Baseline
Objective Wheelchair Mobility
Time frame: 2-weeks
Objective Wheelchair Mobility
Time frame: 6-Month Follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 29018615Giesbrecht EM, Miller WC. A randomized control trial feasibility evaluation of an mHealth intervention for wheelchair skill training among middle-aged and older adults. PeerJ. 2017 Oct 5;5:e3879. doi: 10.7717/peerj.3879. eCollection 2017.
- Background: PubMed 28725451Best 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.
- Background: PubMed 25702375Best 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.
- Background: PubMed 26343171Best 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.
- Background: PubMed 26847009Smith EM, Giesbrecht EM, Mortenson WB, Miller WC. Prevalence of Wheelchair and Scooter Use Among Community-Dwelling Canadians. Phys Ther. 2016 Aug;96(8):1135-42. doi: 10.2522/ptj.20150574. Epub 2016 Feb 4.
- Background: PubMed 29044443Giesbrecht EM, Smith EM, Mortenson WB, Miller WC. Needs for mobility devices, home modifications and personal assistance among Canadians with disabilities. Health Rep. 2017 Aug 16;28(8):9-15.
- Background: PubMed 15208888Shields M. Use of wheelchairs and other mobility support devices. Health Rep. 2004 May;15(3):37-41. No abstract available.
- Background: PubMed 14534060Finlayson M, van Denend T. Experiencing the loss of mobility: perspectives of older adults with MS. Disabil Rehabil. 2003 Oct 21;25(20):1168-80. doi: 10.1080/09638280310001596180.
- Background: PubMed 18566926Simpson RC, LoPresti EF, Cooper RA. How many people would benefit from a smart wheelchair? J Rehabil Res Dev. 2008;45(1):53-71. doi: 10.1682/jrrd.2007.01.0015.
- Background: PubMed 16871856Rudman DL, Hebert D, Reid D. Living in a restricted occupational world: the occupational experiences of stroke survivors who are wheelchair users and their caregivers. Can J Occup Ther. 2006 Jun;73(3):141-52. doi: 10.2182/cjot.05.0014.
- Background: PubMed 7917161Kirby RL, Ackroyd-Stolarz SA, Brown MG, Kirkland SA, MacLeod DA. Wheelchair-related accidents caused by tips and falls among noninstitutionalized users of manually propelled wheelchairs in Nova Scotia. Am J Phys Med Rehabil. 1994 Sep-Oct;73(5):319-30. doi: 10.1097/00002060-199409000-00004.
- Background: PubMed 15839290Gavin-Dreschnack D, Nelson A, Fitzgerald S, Harrow J, Sanchez-Anguiano A, Ahmed S, Powell-Cope G. Wheelchair-related falls: current evidence and directions for improved quality care. J Nurs Care Qual. 2005 Apr-Jun;20(2):119-27. doi: 10.1097/00001786-200504000-00006.
- Dalhousie University. Wheelchair Specifications FormLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Specific individual participant data sets to be shared include all collected IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ed Giesbrecht, PhD principal investigator
University of Manitoba
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TEAM Wheels in people with Mobility Limitation, run by University of Manitoba at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ed Giesbrecht, PhD (204-977-5630, Ed.Giesbrecht@umanitoba.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04090177, which also lists 75 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.