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
研究组 & 干预措施
Bimanual-to-unimanual device home training program
干预措施: m2 Bimanual Arm Trainer (BAT) (Device)
Conventional non-device home training program
Subjects receive 6 weeks of ongoing usual and customary care schedule of home physical and occupational therapy as usual and customary care independent of the study.
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