Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

NCT ID: NCT05805410

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-12-31

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.

Conditions

Child Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

robotic hippotherapy

Intervention Type: BEHAVIORAL

A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.

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.

Group Type: ACTIVE_COMPARATOR

Conventional physical therapy

Intervention Type: BEHAVIORAL

Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.

Interventions

robotic hippotherapy

A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.

Intervention Type: BEHAVIORAL

Conventional physical therapy

Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Ming Wu

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Wu

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ming Wu

Role: CONTACT

w-ming@northwestern.edu

3122380700

Facility Contacts

Ming Wu, PhD

Role: primary

mwu@ric.org

3122380700

Other Identifiers

R01NS115487

Identifier Type: NIH

Identifier Source: org_study_id

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