Clinical trial NCT05564247: Wheelchair Skills Training for Children and Youth
Official title: Effectiveness of the Wheelchair Skills Training Program for Improving Wheelchair Skills and Related Rehabilitation Outcomes Among Children and Youth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wheelchairs
Keywords: manual wheelchair
manual wheelchair skills training
pediatrics
self efficacy
skills capacity
skills performance
satisfaction with participation
actigraphy
Lead sponsor: Laval University
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-site, single-blind randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Wheelchair Skills Test Version 5.2.1 for MWC users
timeFrame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
Secondary outcomes:
measure: MWC Activity (Actigraph)
timeFrame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
measure: Parents Perception of Child's MWC Capacity and Performance Version 5.2.1
timeFrame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
measure: MWC Use Confidence Scale (WheelCon)
timeFrame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
measure: The Wheelchair Outcome Measure for Young People (WhOM-YP)
timeFrame: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
city: Montréal
country: Canada
facility: CHU Ste-Justine
state: Quebec
city: Québec
country: Canada
facility: Universite Laval
state: Quebec
Study officials:
affiliation: Universite Laval
name: Krista Best, PhD
role: PRINCIPAL_INVESTIGATOR
References: