Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 2 Years and 6 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Other: 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.
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.
  • Other: physical therapy
    In this intervention, the child will attend their usual physical therapy sessions.

Recruiting Locations

Fortis Therapy Center
Dripping Springs 4686903, Texas 4736286 78620
Contact:
Elizabeth M Ardolino, PhD
215-605-9319
liz_ardolino@baylor.edu

More Details

Status
Recruiting
Sponsor
Baylor University

Study Contact

Elizabeth Ardolino, PhD, PT
215-605-9319
liz_ardolino@baylor.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.