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TEAM Wheels Training for Limited Mobility (TEAMWheels Trial)
N/A
Recruiting
Led By Ed Giesbrecht, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age and older
Have the ability to propel with both arms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month follow-up (week 31)
Awards & highlights
TEAMWheels Trial Summary
This trial is testing whether a one-month, peer-led eHealth training program can improve satisfaction with activity participation and related rehabilitation outcomes, compared to current wheelchair training practice. The primary objectives are to measure the effect of the program on satisfaction with participation in important activities of life, and to measure retention of benefits at six months post-treatment.
Who is the study for?
This trial is for adults who use a manual wheelchair (MWC) at least part-time, can push themselves with both arms, and understand English. They should live in the community and not be undergoing any other wheelchair skills training or have health issues like cancer or recent surgery that could affect their participation.Check my eligibility
What is being tested?
The TEAM Wheels study tests a peer-led eHealth training program designed to improve satisfaction with activity participation for new manual wheelchair users. It compares this new program's effectiveness against current wheelchair training practices over one month, with follow-up after six months.See study design
What are the potential side effects?
Since this is an educational intervention rather than a medical treatment, traditional side effects are not applicable. However, participants may experience fatigue or muscle soreness from increased physical activity during the training.
TEAMWheels Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can use both of my arms to move myself.
TEAMWheels Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-month follow-up (week 31)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month follow-up (week 31)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Satisfaction with Participation: Wheelchair Outcome Measure (WhOM)
Secondary outcome measures
Objective Wheelchair Mobility
Short Form-36E (Enabled)
Wheelchair Skills Test - Questionnaire (WST-Q)
+1 moreOther outcome measures
Cost
TEAMWheels Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention-TEAM WheelsExperimental Treatment1 Intervention
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.
Group II: Control-Wait ListActive Control1 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.
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Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,713 Total Patients Enrolled
Laval UniversityOTHER
417 Previous Clinical Trials
172,218 Total Patients Enrolled
University of ManitobaLead Sponsor
595 Previous Clinical Trials
199,427 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a health condition that could affect my ability to train.I use a manual wheelchair at least some of the time.I am 18 years old or older.I am currently receiving special mental wellness coaching.I can use both of my arms to move myself.
Research Study Groups:
This trial has the following groups:- Group 1: Control-Wait List
- Group 2: Intervention-TEAM Wheels
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How large is the sample size for this experiment?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is actively searching for enrollees and was initially published on June 1st 2021. The study seeks to have 54 participants at 3 separate sites with the last update being October 31st 2022."
Answered by AI
Is enrollment open for this trial currently?
"Affirmative. Clinicaltrials.gov states that this research study is actively searching for eligible participants and has been since June 1st 2021, with the last update occuring on October 31th 2022. 54 patients from 3 clinical trial sites are required to be admitted into the program."
Answered by AI
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