Neuromuscular Mechanisms of Specific Trunk Interventions in Children With CP

Child Behavior Clinical Trial

Official title:

Neuromuscular Mechanisms of Specific Trunk Interventions in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05805410
• Other study ID #: R01NS115487
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2024
• Source: Shirley Ryan AbilityLab
• Contact: Ming Wu
• Phone: 3122380700
• Email: w-ming[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child Behavior

Intervention

Behavioral:
• robotic hippotherapy
A custom designed cable-driven robotic system that mimics horseback movement during walking was used in this study.
• Conventional physical therapy
Stretching of trunk and leg muscles, followed by sitting and standing balance training, and conventional treadmill walking.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Walking speed from baseline	Overground walking speed	baseline, post 6 weeks of training and 8 weeks after the end of training.
Secondary	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.
Secondary	Change in GMFM-66	Gross Motor Function Measure	baseline, post 6 weeks of training and 8 weeks after the end of training.