Activities-based Locomotor Training in Children With Cerebral Palsy

NCT ID: NCT07184411

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-11
• Study Completion Date: 2028-08-31

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Activities-based locomotor training (AB-LT)

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.

Group Type: EXPERIMENTAL

Activities-based locomotor training

Intervention Type: 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.

Usual care

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.

Group Type: ACTIVE_COMPARATOR

physical therapy

Intervention Type: OTHER

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

Interventions

Activities-based locomotor training

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.

Intervention Type: OTHER

physical therapy

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • 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.

Exclusion Criteria

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

• Uncontrolled epilepsy; and
• Uncontrolled cardiovascular disease

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Baylor University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Ardolino, PhD, PT

Role: PRINCIPAL_INVESTIGATOR

Baylor University

Locations

Fortis Therapy Center

Dripping Springs, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Ardolino, PhD, PT

Role: CONTACT

liz_ardolino@baylor.edu

215-605-9319

Megan Flores, PhD, PT

Role: CONTACT

megan_flores@baylor.edu

Facility Contacts

Elizabeth M Ardolino, PhD

Role: primary

liz_ardolino@baylor.edu

215-605-9319

Megan Flores, PhD

Role: backup

megan_flores@baylor.edu

512-529-4421

Other Identifiers

1R15HD119622-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2245497

Identifier Type: -

Identifier Source: org_study_id