Bike Skills Training for Children With Cerebral Palsy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
研究概览
简要总结
An assessor blinded multi-centre randomized controlled trial will be conducted in which 60 participants will be randomized to either a novel task-specific approach to training bike skills or a parent-led home program comparison group. Baseline assessment will take place within 6 weeks prior to starting the intervention (T0) and outcomes will be assessed within a week following (T1); and at 12 - 14 weeks following (T2) the week long intervention. The primary outcome is attainment of individualised two-wheel bike specific goals at T1. All statistical analysis will be conducted on an intention-to-treat basis. Logistic regression will be used to assess the effect of providing the novel intervention compared to the parent-led home program on bike-specific goal attainment.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Live in Victoria, Australia
- •Diagnosis of cerebral palsy
- •Aged 6 - 15 years
- •Independently ambulant without mobility aids
- •Have goals specific to two-wheel bike skills
- •Have medical clearance to participate
- •Have access to an appropriate bike and helmet
- •Have a primary care giver who understands written and spoken English available to participate for each participant.
排除标准
- •Has a moderate to severe intellectual impairment
- •Has a dual diagnosis with another developmental disability or medical condition that may impact on their ability or safety to train two-wheel bike skills. This includes; Autism Spectrum Disorder, Trisomy 21, spina bifida, uncontrolled epilepsy, significant visual or hearing impairment as determined by medical clearance from the child's general practitioner or paediatrician
- •Had musculoskeletal surgery, or other major surgery including insertion of a baclofen pump that may affect their physical ability, in the 6 months prior to randomisation or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
- •Has Botulinum toxin-A (BonT-A) injections to the lower limbs and/or upper limbs in the 6 months prior to randomisation, or during the intervention and 12 week follow up period (if after randomisation, will be excluded from per-protocol analysis)
研究组 & 干预措施
Novel task-specific program
Intervention arm - see detailed intervention group description below
干预措施: Novel task-specific bike skills training program (Other)
Parent-led home-based program
Comparison arm - see detailed comparison group description below
干预措施: Parent-led home-based bike skills training program (Other)
结局指标
主要结局
Goal attainment at 1 week post the intervention period as measured by the Goal Attainment Scale (GAS)
时间窗: 1 week following intervention
The GAS is a criterion referenced tool for individualized and collaborative goal setting between the child, family and therapist. Two to three individualized goals specific to two-wheel bike riding per participant will be set at the baseline visit with six potential outcomes specified for each goal from (-3 (deterioration), -2 (equal to start), -1 (less than expected), 0 (expected), 1 (somewhat more than expected), 2 (more than expected)). For each goal, attainment is defined as a score of zero or above on the GAS. The primary outcome, goal attainment, will be defined as attainment of at least one goal to an expected (score of zero) or greater level.
次要结局
未报告次要终点
研究者
Rachel Toovey
PhD candidate | Physiotherapist
Murdoch Childrens Research Institute