Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

Study Overview
=================
Brief Summary
-----------------
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.

Detailed Description
-----------------
We will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with CP.

Official Title
-----------------
Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy

Conditions
-----------------
Child Behavior

Intervention / Treatment
-----------------
* Behavioral: robotic hippotherapy
* Behavioral: Conventional physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with a diagnosis of bilateral spastic CP attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of Bax. Children aged 4 to 12 years old without Botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training. Subjects will be able to remain seated without help for ≥10s. GMFCS levels will be I to IV. Children must be able to signal pain, fear or discomfort reliably. Children with mild scoliosis (Cobb angle < 20 °). Children with CP who have no prior hippotherapy experiences within 6 months. Exclusion Criteria: severe lower extremity contractures, fractures, osseous instabilities, osteoporosis. severe disproportional bone growth. unhealed skin lesions in the lower extremities. thromboembolic diseases, cardiovascular instability. aggressive or self-harming behaviors.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to two groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic hippotherapy<br>For the robotic training group, each subject will be trained for 40 minutes. Specifically, each participant will sit astride on a robotic horse with the force perturbation will be applied in the anterior-posterior direction and up/down direction. | Behavioral: robotic hippotherapy<br>* A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.<br>|
| Active Comparator: Conventional physical therapy<br>For the conventional physical therapy group, each subject will be trained for 40 minutes, which will include 10 minutes of stretching, followed by 10 minutes of sitting and 10 minutes of standing balance training, and 10 minutes of treadmill walking. | Behavioral: Conventional physical therapy<br>* Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Trunk Control Measurement Scale (TCMS) score from baseline. | The maximum value for the total TCMS is 58 points (no unit). Specifically, there is 20 points for the category 'static sitting balance', 28 points for 'selective movement control', and 10 points for 'dynamic reaching'). A higher TCMS scores indicates a better motor performance in trunk control. | baseline, post 6 weeks of training and 8 weeks after the end of training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Walking speed from baseline | Overground walking speed | baseline, post 6 weeks of training and 8 weeks after the end of training. | 
| Chang in 6-minute walking distance from baseline | Walking distance within 6 minutes | baseline, post 6 weeks of training and 8 weeks after the end of training. | 
| Change in GMFM-66 | Gross Motor Function Measure | baseline, post 6 weeks of training and 8 weeks after the end of training. |