- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05564247
Wheelchair Skills Training for Children and Youth
Effectiveness of the Wheelchair Skills Training Program for Improving Wheelchair Skills and Related Rehabilitation Outcomes Among Children and Youth
Manual wheelchair (MWC) skills training is a critical component of wheelchair service provision. However, children and youth receive little to no training. MWC training effectively improves MWC skills, self-efficacy and satisfaction with participation (ie., facilitators of independent mobility and social participation) in adults. Independent mobility is especially critical for children, as it is associated with higher likelihood of employment and independent living in adulthood.
Despite evidence of an effective Wheelchair Skills Training Program (WSTP) for adults, very little research has been conducted in the area of wheelchair mobility for children and youth. Two small single-group studies suggest that MWC skills training improves wheelchair skills and satisfaction with participation among individuals ages 4-17 years when training was conducted by professionals (eg. clinicians) and non-professionals (eg. peer-trainers). However, there are no controlled trials documenting the effect of MWC skills training among children and no evidence of best training approaches.
The purpose of this study is to evaluate the efficacy of the WSTP for improving MWC skills, MWC confidence and participation outcomes among children and youth. A randomized controlled trial will establish efficacy of clinician led approaches to training, which may be implemented on a broader community-based scale in the future.
The results of this study will provide critical evidence for best practices for improving MWC mobility during childhood. Deliverables from this study will include MWC skills training tools for clinicians, that will be made freely available through an existing website. The results will support multi-site implementation trials and exploration of community-based approaches to wheelchair skills training for children and use.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Goal. Evaluate the efficacy of the Wheelchair Skills Training Program (WSTP) (ie. the current gold-standard among adults) for improving MWC skills (primary outcome), MWC activity, MWC use self-efficacy, satisfaction with participation, among children and youth ages 4 to 21 years. The influence of the WSTP on parents perception of their child's MWC skills and parent's satisfaction with participation will also be evaluated.
Background: Manual wheelchair (MWC) skills training is a critical component of service provision. Sixteen randomized controlled trials (RCTs) and two meta-analyses demonstrate that a Wheelchair Skills Training Program (WSTP) effectively improves MWC skills among adults. Evidence also suggests that the WSTP can improve self-efficacy for using a MWC and satisfaction with participation (ie. facilitators of independent mobility and social participation). Among children and youth (5-17 years), two quasi-experimental trials have shown improved wheelchair skills and satisfaction with participation when the WSTP was conducted by both professionals (eg. occupational therapists, physiotherapists) and non-professionals (eg. peer-trainers). To date there are no experimental trials evaluating the efficacy of MWC skills training among children and youth, and there is limited evidence on the best approach to training.
Research aims: The purpose is to evaluate the efficacy of the WSTP, for improving wheelchair skills (primary outcome), parent-perceived wheelchair skills, satisfaction with participation in meaningful activities, wheelchair use self-efficacy, and health-related quality of life among children and youth, compared to usual wheelchair training practice, and to measure the retention of benefits 6 months later.
Methods: A 3-site (Quebec City, Montreal, Halifax) RCT will be conducted in both official languages. Forty-eight children and youth ages 4-21 years will be randomized (stratified by site and by age groups {ie. 4-7, 8-11, 12-16, and 17-21}) to the intervention group or control group. The intervention group will receive 10 sessions of the WSTP (modified for children and youth) facilitated by healthcare professionals (e.g., occupational therapists, physiatrists). The control group will receive an attention control and usual wheelchair provision and services at each site. Between-group analysis will be conducted with primary (wheelchair skills) and secondary outcomes (parent-perceived wheelchair skills, satisfaction with participation, self-efficacy and health-related quality of life and a 6-month follow-up will be conducted. Qualitative interviews will explore experiential aspects of participation.
Core expertise. World leaders in wheelchair skills training (ie, developers of the WSTP) form this pan-Canadian interdisciplinary team. The study team has expertise in administering the WSTP and all outcomes in English and French, implementation of multi-site RCTs, and recruitment of wheelchair users. Clinical and community collaborators are interested in adopting the WSTP for use in child and youth populations and have committed their support to this project.
Expected outcomes: Demonstrating the efficacy of the WSTP for children and youth will provide an evidence-based program that is ready for uptake by healthcare professionals and possibly scalable for community-based professionals and non-professionals across Canada and the world. Working with clinical and community partners will position us to negotiate knowledge dissemination and sustainability of an efficacious program. The WSTP may improve independent mobility, confidence and participation outcomes in children and youth of various ages, while reducing risk of injury and burden on parents and families. Independent mobility during childhood is associated with higher likelihood of employment and independent living in adulthood.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Krista Best, PhD
- Phone Number: 418-529-9141
- Email: krista.best@fmed.ulaval.ca
Study Contact Backup
- Name: Jordan Sheriko, MD
- Phone Number: 902-470-7099
- Email: Jordan.Sheriko@iwk.nshealth.ca
Study Locations
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Nova Scotia
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Halifax, Nova Scotia, Canada
- Not yet recruiting
- IWK Health Centre
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Contact:
- Jordan Sheriko
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Quebec
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Montréal, Quebec, Canada
- Not yet recruiting
- CHU Ste-Justine
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Contact:
- Paula Rushton, PhD
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Québec, Quebec, Canada, G1M2S8
- Recruiting
- Universite Laval
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Contact:
- Krista Best, PhD
- Phone Number: 418-529-9141
- Email: krista.best@fmed.ulaval.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- have their own Manual Wheelchair (MWC)
- able to self-propel MWC for a minimum distance of 10 metres, without assistance
- able to follow a two-step command (evaluated by person conducting eligibility screening)
Exclusion Criteria:
- anticipate health conditions/procedures that contraindicate training in the next 6 months (e.g. surgery)
- have a degenerative condition that is expected to progress quickly
- will be/ are attending MWC skills training
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Group (WSTP)
Participants will complete 12, 45-minute weekly sessions of WSTP delivered by clinicians with >5 years of experience working with children who use MWC.
Trainers will customize each session based on the age group (child or adolescent) and training goals of each child as determined in session one.
Subsequent sessions will begin with a 5-minute review of progress and socializing, followed by a 10-minute warm-up (random practice of the previously learned skills); 20 minutes of attempting new skills (training on each skill will be carried to next session until the skills are learned or until the trainer and participant mutually agree that training should be abandoned; the trainer will periodically ask the participant to practice newly learned skills to incorporate variability of practice); 10 minute cool-down, during which the participant will practice skills in a self-controlled environment.
Age-appropriate considerations are incorporated into training materials
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Participants will complete customized MWC skills training based on the evidence-based wheelchair skills program.
Lessons plans will be created by the clinicians, children and parents participants based on goals, age, skills and interests, and used to customize the training.
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No Intervention: Control Group (Attention)
Participants will be attention-matched to mimic time and contacts of the experimental group.
The control group will receive 12, 45-minute weekly sessions of 'Games and Activities' facilitated by healthcare professionals (e.g., occupational therapy/rehabilitation students) who will not be involved in the intervention or any other aspect of the study.
The control group facilitator will mimic the same type of attention as the training at each site (i.e., sessions will be held at healthcare facilities and in the community (e.g., libraries, shopping centres, museums, parks).
Facilitators will be equipped with current popular games and activities (according to social media and websites of popular children's stores) kits that include various board and card games, hand-eye coordination games, active games, cognitive activities, and arts and crafts suitable for children and adolescents to ensure interest and acceptability for all participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheelchair Skills Test Version 5.2.1 for MWC users
Time Frame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Change in MWC skills capacity (i.e., what a person can do in a standardized environment), and frequency of performance will be assessed using the Wheelchair Skills Test (WST).
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Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MWC Activity (Actigraph)
Time Frame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Change in objective MWC activity will be collected to triangulate measurement of improvement in MWC skills and engagement in community activities using a triaxial accelerometer (Actigraph GT3X, Pensacola FL).
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Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Parents Perception of Child's MWC Capacity and Performance Version 5.2.1
Time Frame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Change in parents' ratings of their child's performance each of the 33 skills on the WST-Q.
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Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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MWC Use Confidence Scale (WheelCon)
Time Frame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Change in perceived self-efficacy for wheelchair use.
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Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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The Wheelchair Outcome Measure for Young People (WhOM-YP)
Time Frame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Change in ratings of satisfaction with social participation and activity performances in a wheelchair.
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Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Krista Best, PhD, Universite Laval
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- WSP-Ped2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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