Home Based Adaptive Arm Training for Children With Hemiplegia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
研究概览
简要总结
Twenty pediatric patients aged 5-17 years with Acquired Brain Injuries (ABI) will be randomized to receive either a bimanual-to-unimanual device home training program (10 subjects) or a conventional non-device home training program (10 subjects) for a period of 6 weeks.
The specific aims of this proposal are to:
Aim 1: Introduce home-based targeted upper limb training in children with hemiplegia from ABI (Acquired Brain Injuries) using a bimanual-to-unimanual training approach It is hypothesized that child-friendly home-based upper limb bimanual-to-unimanual training will lead to greater compliance and improved motor outcome on the Fugl Myer Scale compared to a conventional home training program.
Aim 2: Improve the understanding of the pattern of recovery of isolated joint movements in the pediatric population with hemiplegia following ABI.
It is hypothesized that individuals receiving device-based bimanual-to-unimanual training will show improvement in active range of motion across upper limb joints compared with a conventional home training program.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acquired Brain Injury at least 3 months prior to enrollment.
- •Unilateral hemiparesis
- •History of compliance with home exercise programs in the past.
排除标准
- •Any social or medical problem that precludes compliance with the protocol
- •Comorbid seizure disorder or other neurological disease
- •Treatment with botulinum toxin or intrathecal baclofen in the 3 months preceding enrollment
- •Implanted neuromodulatory or electronic device or other complicating illness
- •Lack of capacity to consent
结局指标
主要结局
Change From Baseline in Timed Performance of Standardized Manual Activities Measured by Hand Assessment Test
时间窗: 6 Weeks
Change From Baseline in Quality of Bimanual Hand Measured by Fugl-Meyer Scale
时间窗: 6 Weeks
Measure of impairments in motor functioning and recovery in children post hemiplegia.
次要结局
未报告次要终点