A "MOtor Learning Based Intervention for Lower Extremities (MOBILE)" to Target Walking Performance in Ambulant Children With Cerebral Palsy: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Fidelity to Intervention Protocol
研究概览
简要总结
The goal of this clinical trial is to learn if a new therapy approach to improve walking ability in children with Cerebral Palsy is acceptable to the children and the families in a community setting.
The main questions we look to answer are:
- Do the children/teens tolerate the therapy and feel that it is helpful?
- Do the parents/ families feel the therapy helps and is easy to commit to?
- Do the children/teens complete all their therapy sessions and assessments as planned?
The participants will trial the therapy for 30 hours over 6 weeks and will perform assessments before and after to see if they meet their goals. They will also be interviewed to see how they felt about the therapy when they finish.
详细描述
The therapy being trialed in this study uses motor learning theory to try and improve or change walking patterns to improve the child/teen's walking goal.
Therapy will target their own walking goal and they can choose the format of their therapy as long as they complete 30 hours of which 24 hours must be in the clinic within a 6 week period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Cerebral Palsy (GMFCS Levels I-III)
- •Has a specific walking related goal
- •Has capacity to follow instruction
- •Has a primary caregiver who can support a home program
排除标准
- •Has had surgery within 6 months of intervention start date
- •Has had botox/ baclofen within 3 months of intervention start date
- •Has a dual diagnosis that impacts ability to follow instruction
- •Has a significant cognitive impairment
研究组 & 干预措施
Intervention
Participants will undergo 30 hours of therapy over 6 weeks in format of their choosing.
A minimum of 24 hours must be completed in clinic with the rest made up of home program.
干预措施: MOBILE (Other)
结局指标
主要结局
Fidelity to Intervention Protocol
时间窗: Duration of study 2 years
Checklist to measure extent of motor learning principles included in sessions
Adherence to Intervention
时间窗: Duration of study 2 years
Percentage of total hours practiced/ planned dose (30 hours)
Feasibility of Outcome Measures (Participant)
时间窗: Duration of study 2 years
Participant experience of outcomes captured by semi-structured interviews.
Acceptability of Intervention
时间窗: Duration of study 2 years
Semi-structured interviews of participants and parents to capture acceptability of intervention using Framework of acceptability
Retention
时间窗: Duration of study 2 years
Percentage of recruited participants at final follow up
Adverse Events
时间窗: Duration of study 2 years
Measured as Yes or No with description
Recruitment Rate
时间窗: rolling recruitment over 1.5 years
Percentage of eligible numbers recruited
Time taken to complete Outcome Measures
时间窗: Duration of study 2 years
Measured in Minutes
Feasibility of Outcome Measures (Assessor)
时间窗: Duration of study 2 years
Assessor experience of outcomes captured by semi-structured interview.
次要结局
- Gait Outcome Assessment List(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- 10 meter self-selected walking speed(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- Modified timed up and go(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- 6 minute walk test(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- ankle and knee Range of motion(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
- Child Health Utilities Index CHU-9D(baseline, upon completion of intervention (2-6 weeks) and 3 month follow up, rolling through duration of study 2 years)
研究者
Catriona O'Shaughnessy
Professional Doctorate Scholar
Royal College of Surgeons, Ireland