Activities-based Locomotor Training in Children With Cerebral Palsy

NCT07184411 | Recruiting DMC

• 2 other identifiers: 22454971R15HD119622-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral Palsy; Locomotor Training; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure (GMFM-66)

  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).

  4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.

Secondary Outcomes (2)

• functional near infrared spectroscopy (fNIRS)

  4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.

• Child Engagement in Daily Life (CEDL)

  4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.

Study Arms (2)

Activities-based locomotor training (AB-LT)

EXPERIMENTAL

Child will participate in a 3-week intensive AB-LT training program. The child will attend the AB-LT session for a total of 3 hours, 5 days a week for 3 weeks. The AB-LT session will consist of 1 hour of walking and standing in a harness on a treadmill, followed by an hour of play-based physical therapy, then followed by a final 1 hour of walking and standing in a harness on a treadmill. All sessions will be run by a licensed physical therapist who is trained in AB-LT.

Other: Activities-based locomotor training

Usual care

ACTIVE COMPARATOR

During this arm, the child will resume or continue their usual therapy schedule, which may include physical therapy, occupational therapy, and/or speech language pathology. No restrictions will be placed on the type or amount of therapy in which the child can participate.

Other: physical therapy

Interventions

Activities-based locomotor training OTHER

Activities-based locomotor training involves placing the child in a partial body-weight supported (PBWS) system over a treadmill. The child is given assistance by trained clinicians to attempt standing and walking on the treadmill for 1 hour. The child then participates in play-based activities aimed to foster independence in an overground (regular) environment for 1 hour. The final hour of the 3-hour session is conducted in the PBWS system with a focus on standing and walking.

Activities-based locomotor training (AB-LT)

physical therapy OTHER

In this intervention, the child will attend their usual physical therapy sessions.

Usual care

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 walking as primary means of mobility;
• 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.

You may not qualify if:

• Surgery or botulinum toxin injections in the previous 6 months;
• Uncontrolled epilepsy; and
• Uncontrolled cardiovascular disease

Sponsors & Collaborators

• Baylor University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Fortis Therapy Center

Dripping Springs, Texas, 78620, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Elizabeth Ardolino, PhD, PT

  Baylor University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Ardolino, PhD, PT

CONTACT

215-605-9319; liz_ardolino@baylor.edu

Megan Flores, PhD, PT

CONTACT

megan_flores@baylor.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: January 11, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be made available at the time of associated publication or by the end of the project, whichever comes first. Data will be available in REDCap for at least 10 years.

Locations

US (1)