Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

Not Applicable

Recruiting

• Conditions: Child Behavior
• Interventions: Behavioral: robotic hippotherapy; Behavioral: Conventional physical therapy

• Registration Number: NCT05805410
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-04-07
• Study First Posted: 2023-04-10
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic hippotherapy	robotic hippotherapy	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.
Conventional physical therapy	Conventional physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Trunk Control Measurement Scale (TCMS) score from baseline.	baseline, post 6 weeks of training and 8 weeks after the end of training.	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States