Activities-based Locomotor Training in Children With Cerebral Palsy

Not Applicable

Not yet recruiting

• Conditions: Cerebral Palsy (CP)

• Registration Number: NCT07184411
• Lead Sponsor: Baylor University

Brief Summary

This project aims to improve the quality of life and functional outcomes for young non-ambulatory children with Cerebral Palsy (CP) by investigating the efficacy of an Activities-Based Locomotor Training (AB-LT) program compared to usual care. By targeting the body structures, activities, and participation components of the World Health Organization's International Classification of Functioning, Disability, and Health (ICF) framework, this study seeks to enhance our understanding of neuroplasticity and motor learning in this population, offering a novel approach to rehabilitation. Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately lower the long-term healthcare needs associated with CP.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-15
• Last Update Submitted: 2025-09-15
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2026-01-05
• Primary Completion: 2028-05
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

To be eligible for this study, the child must be:

• • Able to hold their head upright for 5 seconds when supported at the trunk in sitting (the minimal amount of head control necessary for safe walking on the partial body weight support system during the AB-LT intervention);

  • Non-ambulatory or not able to walk more than 10' without assistance, with or without an assistive device;
  • Willing to attend the AB-LT intervention at Fortis Therapy Center in Dripping Springs, Texas for 3 hours/ day, 5 days/week, for 3 weeks; and
  • Willing to commit to a total of 7 weeks of the study, and to continue their usual care during the time period in which they are not enrolled in the AB-LT intervention.

Exclusion Criteria

The child must not have:

• • Surgery or botulinum toxin injections in the previous 6 months;

  • Uncontrolled epilepsy; and
  • Uncontrolled cardiovascular disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Gross Motor Function Measure (GMFM-66)	4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.	The GMFM-66 is the gold standard for measuring gross motor function in children with CP. A child's capabilities are scored across five dimensions (66 items), including Lying and Rolling (Dimension A), Sitting (Dimension B), Crawling and Kneeling (Dimension C), Standing (Dimension D), and Walking, Running, and Jumping (Dimension E).

Secondary Outcome Measures

Name	Time	Method
functional near infrared spectroscopy (fNIRS)	4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.	functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique that uses infrared light to assess hemodynamic shifts in the prefrontal cortex during movement. It involves wearing a lightweight neoprene headband that contains sensors.
Child Engagement in Daily Life (CEDL)	4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.	The Child Engagement in Daily Life (CEDL) is a survey completed by parents or caregivers of children, 18 months through 12 years of age. The CEDL describes a child's participation in daily activities such as interactions with others, play, and self-care.