Blinded, Randomized Trial Comparing Constraint Induced Movement Therapy With Virtual Reality to Constraint Induced Movement Therapy Alone and the Correlation of Patient Characteristics With Responsiveness to Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Assisting Hand Assessment (AHA)
研究概览
简要总结
This study is being done to compare constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) and its impact on how the children with unilateral cerebral palsy use their arm. CIMT is an intensive upper limb therapy for children with one sided (unilateral) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Both groups will work on using both arms together to complete activities (bimanual training) as a way to transfer newly learned skills with one hand into two handed tasks. Assessments before and after the intervention will include clinical assessments (where a research team member observes the child doing tasks and ask questions), motion capture (where the child's movement is recorded using multiple cameras), and wearable sensors on the wrists (like a watch).
详细描述
The purpose of this research study is to compare the effectiveness of constraint induced movement therapy (CIMT) to CIMT combined with virtual reality technology (CIMT+VR) in children with unilateral cerebral palsy. Both groups will also work on bimanual training (using both arms together to complete activities) as a way to transfer newly learned skills with one hand into two handed tasks. One group will receive CIMT, and the other group will receive CIMT and the VR technology. CIMT is an intensive upper limb therapy for children with unilateral (one sided) cerebral palsy where the child wears a constraint (splint or mit) on their dominant hand so that they use the involved (weaker) side to do activities. Participants in the CIMT+VR group of this study protocol will do everything the CIMT group does PLUS will utilize at least 4 of the following VR technologies each day of intervention: FitMi, Tyromotion Pablo Upper Extremity, Hocoma Armeo® Spring Pediatric, Nintendo Wii, and Parrot Drone.
FitMi is a neurorehabilitation device that provides visual feedback on motor performance as the individual interacts with wireless switches (Flint Rehab, 2020). The targeted areas of upper limb function for the study include grasp, release, and thumb opposition.
Tyromotion Pablo® Upper Extremity is a sensor based rehabilitation device with interactive therapies for the whole body. It provides targeted training for pronation/supination and force regulation for gross grasp, tip pinch, lateral and three point pinch (Tyromotion). The targeted areas of upper limb function for the study include supination, grip strength, and pinch strength.
Hocoma Armeo® Spring Pediatric is a device that combines the assistance of an exoskeleton and VR games created to improve hand function in the pediatric population. The Hocoma Armeo ® Spring Pediatric encourages repetitive movement of the UL with the aim of increasing quantity and improving quality of movements and can be customized for range of motion and the amount of gravity assistance the exoskeleton provides the child while playing the VR games. The targeted areas of upper limb function for the study include upper arm movement and wrist extension.
Nintendo Wii® is a video game console that uses a handheld pointing device that detects movement in three directions. The system requires the individual to hold the controller in the hand while moving the upper extremity. The targeted areas of upper limb function for the study include stabilize and hold. Parrot Drone is a stable quadcopter mini drone that can be flown indoors and outdoors. It has an autopilot feature that keeps the drone steady even if the user lets go of the controller. The drone can be controlled with a remote control or from a smart device that will target isolated finger and thumb movements.
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 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have cerebral palsy (a brain injury that causes muscle movement problems) or are a non-progressive brain injury to the developing brain and have difficulty using one of your arms
排除标准
- •unable to complete assessment protocol
结局指标
主要结局
Assisting Hand Assessment (AHA)
时间窗: Baseline, pre-intervention and immediate post-intervention
assessment of bimanual hand skills in children with cerebral palsy well the involved hand performs during two handed activities,
次要结局
- Canadian Occupational Performance Measure Occupational Performance Measure (COPM)(Baseline, pre-intervention and immediate post-intervention)
- Melbourne Unilateral Upper Limb Assessment (MUUL)(Baseline, pre-intervention and immediate post-intervention)
- ICF Brief Core Set for Cerebral Palsy(Baseline, pre-intervention)
- sensory assessment(Baseline, pre-intervention and immediate post-intervention)
- motion capture with electromyography (EMG)(Baseline, pre-intervention and immediate post-intervention)
- option wearing of ActiGraphs on upper limbs(Baseline, pre-intervention and immediate post-intervention)
- Hypertonia Assessment Tool Assessment Tool (HAT)(Baseline, pre-intervention and immediate post-intervention)