Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

NCT05805410 | Recruiting DMC

• 1 other identifier: R01NS115487
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.

Conditions

Child Behavior

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Walking speed from baseline

  baseline, post 6 weeks of training and 8 weeks after the end of training.

• Chang in 6-minute walking distance from baseline

  baseline, post 6 weeks of training and 8 weeks after the end of training.

• Change in GMFM-66

  baseline, post 6 weeks of training and 8 weeks after the end of training.

Study Arms (2)

Robotic hippotherapy

EXPERIMENTAL

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

Conventional physical therapy

ACTIVE COMPARATOR

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

Interventions

robotic hippotherapy BEHAVIORAL

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

Robotic hippotherapy

Conventional physical therapy BEHAVIORAL

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

Conventional physical therapy

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ming Wu

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Wu

CONTACT

3122380700; w-ming@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Participants will be randomly assigned to two groups

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: April 10, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)