Sensory Stimulation During Constraint-Induced Movement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Feasibility (Total Number of Hours That Participants Wear the Device)
研究概览
简要总结
The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.
详细描述
The stimulation is peripheral sensory stimulation involving application of low-level, random-frequency vibration to the wrist skin. The hypothesis is that improvement in upper extremity function will be greater for the experimental group receiving the stimulation during CIMT compared with the control group who will wear the device with no vibration (placebo). This pilot study is to assess feasibility and safety.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A double-blinded stratified randomized controlled trial
入排标准
- 年龄范围
- 3 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 3 and 9
- •Have unilateral upper limb motor weakness.
- •Use the affected extremity as a gross assist during play and self-care activities.
- •No significant developmental delays that would limit spontaneous use of the more affected extremity.
- •Be ambulatory for their age and demonstrate intact balance and protective reactions throughout the less involved upper extremity.
- •No other health impairment other than hemiparesis.
排除标准
- 未提供
研究组 & 干预措施
Vibration
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
干预措施: Standardized Constraint-Induced Movement Therapy (Behavioral)
Vibration
The experimental group will receive the wrist stimulation during standardized Constraint-Induced Movement Therapy.
干预措施: Vibration (Behavioral)
No Vibration
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
- The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
干预措施: Standardized Constraint-Induced Movement Therapy (Behavioral)
No Vibration
The control group will wear the vibration device with no vibration during standardized Constraint-Induced Movement Therapy.
- The vibration device is a generic, commercially-available, vibrator, not particularly used for this peripheral skin stimulation purpose.
干预措施: Placebo (for vibration) (Behavioral)
结局指标
主要结局
Feasibility (Total Number of Hours That Participants Wear the Device)
时间窗: through 5-day study completion.
total number of hours that participants wear the device
次要结局
未报告次要终点