Home- and Lab-Based Passive and Active Movement Rehabilitation of Ankle Impairments in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Changes of Active Range of Motion (AROM)
研究概览
简要总结
The purpose of the study is to examine the outcomes of home-based robot-guided therapy and compare it to laboratory-based robot-guided therapy for impaired ankles in cerebral palsy. Children with spastic cerebral palsy (CP) are randomly placed into two groups, participating in robot-guided stretching and active movement training either in a research lab setting (Lab group) or in a home setting (Home group).
详细描述
Children with spastic CP will be randomly placed to 2 groups, either a Lab group or a Home group. For both groups, the participation will involve 18 training sessions over 6 weeks with 3 sessions each week. Each training session will last about 45 minutes, including stretching and active movement training.
The participant will be asked to sit with the foot secured to a footplate and leg fixed by a leg-support. Once the rehab robot is on the child's ankle, the investigator will first determine maximum range of motion that is safe for the ankle stretching. The robot will then move the ankle joint slowly within the set range of motion, and stretch the ankle back and forth. The passive stretching will help loosen the child's muscle and increase range of motion in the ankle joint. Passive stretching will last about 15 minutes.
After stretching, the investigator will ask the child to move and control the ankle joint back and forth to complete video-game tasks. While the child moves the ankle, the robot will provide assistance or resistance to improve control of the ankle joint. Active movement training will last about 20 minutes.
For Home group, the family members will be trained by the research team at the lab on how they use the rehab robot properly. On the day of the first assessment, the investigator will go through the device operation with family members. A detailed user manual will be given. The investigator will allow the family members and the child to practice using the device as many times as needed until the participant feel comfortable using the device at home. The family members should prepare for a minimum of one hour for this instructional period to learn the device, but they will be allowed as much time as needed.
Before leaving UMB to begin at-home training, the family members will be checked for the competency of using the device. The family members will be asked to go through each step without any direct assistance with the research staff. The family members may use their own vehicle to take the portable rehab robot home. While the family members are doing training for the child at home, the training data will be saved automatically in the laptop with the rehab robot.
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
- 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
- •Spastic cerebral palsy with diplegia or hemiplegia (affected both legs or one leg)
- •6-17 years old
- •Can follow instructions and express any discomfort during the sessions.
排除标准
- •Orthopedic surgery, serial casting, or injection of muscle relaxants such as botulinum toxin type A within 6 months prior to participation in the study
- •Severe ankle contracture, greater than 20° plantar flexion
- •Other unrelated neurological impairments or musculoskeletal injuries
- •Can not sit for 1 hour
研究组 & 干预措施
Lab group
Lab-based intervention includes 18 training sessions using the IntelliStretch in the lab .
干预措施: IntelliStretch (Device)
Home group
Home-based intervention includes 18 training sessions using the IntelliStretch at home.
干预措施: IntelliStretch (Device)
结局指标
主要结局
Changes of Active Range of Motion (AROM)
时间窗: AROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.
The subjects will be asked to use their muscles to move the ankle joint and record the range of motion by the robot.
次要结局
- Changes of Modified Ashworth Scale (MAS)(MAS will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
- Changes of Selective Control Assessment of Lower Extremity (SCALE)(SCALE will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
- Changes of Pediatric Balance Scale (PBS)(PBS will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
- Changes of the Timed Up and Go Test (TUG)(TUG will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
- Changes of 6 Minute Walk Test (6MWT)(6MWT will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
- Changes of Passive Range of Motion (PROM)(PROM will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
- Changes of the muscle strength(The muscle strength will be assessed at 3 time points: at the beginning and the end of 6-week training, and follow-up at 6 weeks after the training ends.)
研究者
Li-Qun Zhang
Professor
University of Maryland, Baltimore