Recruiting

AB-LT

Sponsor:

Baylor University

Code:

NCT07184411

Conditions

Cerebral Palsy (CP)

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

Interventions

Activities-based locomotor training

physical therapy

Study Details

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 ID

NCT07184411

Start date

Jan 11, 2026

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

May 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 6

Healthy Volunteers: Not accepted

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 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: The child must not have:

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

  • Uncontrolled epilepsy; and
  • Uncontrolled cardiovascular disease

Study Design

Enrollment

19 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

physical therapy

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

Primary outcome measure

  • Gross Motor Function Measure (GMFM-66) [ Time Frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7. ]

Central Contacts and Locations

Central contacts

Elizabeth Ardolino, PhD, PT

215-605-9319liz_ardolino@baylor.edu

Megan Flores, PhD, PT

megan_flores@baylor.edu

Locations

Fortis Therapy Center

Recruiting

Dripping Springs, Texas, United States, 78620

Contacts

Elizabeth M Ardolino, PhD

215-605-9319liz_ardolino@baylor.edu

Megan Flores, PhD

512-529-4421megan_flores@baylor.edu

Principal Investigator:

Elizabeth M Ardolino, PhD

More Information

Sponsor

Baylor University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • Cerebral Palsy
  • Locomotor Training
  • Physical Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Baylor University on 2026-08-24.