Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change in Box and Blocks Test (BBT) after intervention
研究概览
简要总结
The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).
详细描述
This study is a prospective Clinical Randomized Control Trial (RCT) in a group of 82 children with cerebral palsy. The experimental and control groups will receive effective postural-reaching training based on motor learning and control principles. In both groups, participants will engage in play and functional activities that elicit arm movement and challenge trunk postural control, and the motor tasks and activities will be progressed. The main difference is that the experimental group will be trained with TruST in order to add postural task-progression via assistive force fields; which will be tailored to the child's sitting control balance status across training sessions. However, in the control group, postural task-progression will be addressed by lowering the level of rigid trunk support segment by segment across training sessions. The trunk subregion where the support is placed will depend on the child's trunk control ability. Participants will be recruited from the United States.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 6-17 years
- •Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
- •Gross Motor Function Classification Systems-Expanded & Review (GMFCS) levels III or IV
- •Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)
- •Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")
排除标准
- •Absent head control (SATCo = 1)
- •Current medical illness unrelated to CP at the time of the study
- •Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements
- •History of recurrent seizures (daily) or drug-resistance epilepsy
- •Severe Spinal Deformities: scoliosis >40◦ and/or kyphosis >45◦
- •Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months
- •Severe spasticity of biceps/triceps in both upper extremities (Modified Ashworth Scale = 4)
- •Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study
- •Other major surgeries in the previous 6 months (if medically contraindicated)
结局指标
主要结局
Change in Box and Blocks Test (BBT) after intervention
时间窗: Through study completion, an average of 4 months
The BBT examines manual dexterity. The child moves the maximum number of blocks (2.5cm2), one at a time, between the compartments of a partitioned box within 60s. B\&B is sensitive to post-intervention changes with the more- and less-affected hand. Arm displacement and grasping will be analyzed with Datavyu. An instruction manual has been created to standardize video-coding procedures and define the reaching variables. Grasping will be defined from the moment the hand contacts the block to the time this is lifted from the surface. Arm displacement will be defined from end of grasping to block release. Reaching performance will be the summation of grasping and arm displacement. Two coders will be used to determine video-coding reliability.
Change in Modified Functional Reach Test (mFRT) after intervention
时间窗: Through study completion, an average of 4 months
The mFRT measures proactive postural control during maximum reaching distance. It is a valid and reliable tool in CP; and it discriminates GMFCS levels.
Change in Postural Star-Sitting Test (PSST) after intervention
时间窗: Through study completion, an average of 4 months
The PSST will be performed before and after interventions to monitor sitting control progression in both TruST- and control-intervention groups. The investigators have several motivations that rationalize this customized measurement. It: 1) is age-appropriate, 2) is goal-oriented, 3) directly measures sitting based on trunk control improvements, 4) is responsive to capture sitting workspace area increases, and 5) offers data with a straightforward functional interpretation.
次要结局
- Change in Canadian Occupational Performance Measure (COPM) after intervention(Through study completion, an average of 4 months)
- Change in Seated Postural & Reaching Control (SP&R-co) after intervention(Through study completion, an average of 4 months)
- Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention(Through study completion, an average of 4 months)
- Change in Segmental Assessment of Trunk Control (SATCo) after intervention(Through study completion, an average of 4 months)
- Change in Postural and Reaching Kinematics after intervention(Through study completion, an average of 4 months)
- Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention(Through study completion, an average of 4 months)