Effectiveness of the Wheelchair Skills Training Program for Improving Wheelchair Skills and Related Rehabilitation Outcomes Among Children and Youth
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Wheelchair Skills Test Version 5.3.1 for MWC users
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Testers will remain blinded to group assignment throughout the study. A Research Coordinator (Quebec site) will coordinate T2 and T3 assessments for both groups.
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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
干预措施: Wheelchair Skills Training Program (WSTP) (Behavioral)
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.
结局指标
主要结局
Wheelchair Skills Test Version 5.3.1 for MWC users
时间窗: Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3)
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). Each item is scored on a scale from 0 to 3, with 0= not capable to perform the skill (or not safely), 1 = can perform the skill partially; 2= can perform the skill (but has room for improvement); 3= can perform the skill at an expert level. A percent score is calculated, with higher percentage = higher skills.
次要结局
- The Wheelchair Outcome Measure for Young People (WhOM-YP)(Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3))
- MWC Use Confidence Scale (Wheel use confidence scale)(Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3))
- Manual Wheelchair Activity (Actigraph)(Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3))
- Parents Perception of Child's MWC Capacity and Performance Version 5.2.1(Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3))
- The Wheelchair Outcome Measure for Young People (WhOM-YP)(Baseline (T1); immediately post intervention up to 12 weeks after baseline (T2); 6-months follow-up (T3))