Activities-based Locomotor Training in Children With Cerebral Palsy

Part of paid clinical trials in Dripping Springs, Texas.

Sponsor
Baylor University
Study ID
NCT07184411
Status
Recruiting
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Conditions

  • Cerebral Palsy (CP)

Eligibility Criteria

Sex
ALL
Age
2 Years - 6 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Jan 11, 2026
Status verified
Dec 2025
Primary completion
May 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
19 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Fortis Therapy CenterDripping SpringsTexas78620
Elizabeth M Ardolino, PhD
[email protected]
215-605-9319
Megan Flores, PhD
[email protected]
512-529-4421
Elizabeth M Ardolino, PhD (PRINCIPAL_INVESTIGATOR)

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Fortis Therapy Center· Dripping Springs, TX

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