Activities-based Locomotor Training in Children With Cerebral Palsy (ENGAGE-CP)

Baylor University

Status: Enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Other: physical therapy; Other: Activities-based locomotor training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07184411

2245497

1R15HD119622-01 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 19 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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19 participants in 2 patient groups

Activities-based locomotor training (AB-LT)

Experimental group

Description:

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.

Treatment:

Other: Activities-based locomotor training

Usual care

Active Comparator group

Description:

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.

Treatment:

Other: physical therapy