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NCT Number: NCT05805410

Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

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

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Key information

Conditions

Child Behavior Behavior

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Ming Wu, PhD

CONTACT

[email protected]

3122380700

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

robotic hippotherapy

Behavioral

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

Conventional Physical Therapy

Behavioral

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

Primary outcomes

  1. Change in Trunk Control Measurement Scale (TCMS) score from baseline.

    Time frame: 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 outcomes

  1. Change in Walking speed from baseline

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

    Overground walking speed

  2. Chang in 6-minute walking distance from baseline

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

    Walking distance within 6 minutes

  3. Change in GMFM-66

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

    Gross Motor Function Measure

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Wu

CONTACT

[email protected]

3122380700

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 10, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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