Actively Recruiting
Efficacy of Activities-based Locomotor Training in Children With Cerebral Palsy
Led by Baylor University · Updated on 2025-12-03
19
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
B
Baylor University
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an Activities-Based Locomotor Training (AB-LT) program compared to usual care to improve the quality of life and motor function in young children with Cerebral Palsy (CP) who are not able to walk independently. This study focuses on children aged 2 to 6 years and aims to understand how targeted physical activities can enhance brain function and movement, potentially leading to better, personalized therapies and reduced long-term healthcare needs. Participants in the study will be randomly assigned to either the AB-LT program or continue with their usual care. The AB-LT intervention involves a 3-week intensive training where children attend sessions 5 days a week, each lasting 3 hours. Each session includes walking and standing in a harness on a treadmill for 1 hour, followed by 1 hour of play-based physical therapy to encourage independence, and finishing with another hour of treadmill walking and standing. The usual care group continues their regular therapy schedule, which may include physical, occupational, or speech therapy with no restrictions on therapy type or amount. During the study, children will be assessed at four times: at the start, after 3 weeks, after 4 weeks, and after 7 weeks. Assessments include measuring gross motor function using the GMFM-66, brain activity with functional near infrared spectroscopy (fNIRS), and daily life engagement with the Child Engagement in Daily Life (CEDL) tool. The study lasts a total of 7 weeks, and children continue their usual care when not participating in the AB-LT sessions. Licensed physical therapists trained in AB-LT will supervise all intervention sessions to monitor progress and safety.
CONDITIONS
Brief Title
Activities-based Locomotor Training in Children With Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child is between 2 and 6 years old
- Able to hold head upright for at least 5 seconds when supported at the trunk in sitting
- Child is non-ambulatory or does not walk as the primary means of mobility
- Willing to attend the AB-LT intervention for 3 hours per day, 5 days a week, for 3 weeks
- Willing to commit to the full 7 weeks of study participation and continue usual care when not in AB-LT
You will not qualify if you...
- Surgery or botulinum toxin injections within the last 6 months
- Uncontrolled epilepsy
- Uncontrolled cardiovascular disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive intensive activities-based locomotor training consisting of 3-hour sessions, 5 days a week for 3 weeks. Each session includes walking and standing in a harness on a treadmill, play-based physical therapy, and additional walking and standing in the harness.
15 sessions (in-person) over 3 weeks
Duration - 3 weeks
Participants continue their usual care including physical therapy, occupational therapy, and/or speech language pathology without restrictions on type or amount of therapy.
Varies per participant; usual therapy schedule
Duration - 4 weeks
Participants are assessed for functional outcomes after the treatment periods, including motor function and brain activity measures.
3 visits (in-person) after treatment
Trial Site Locations
Total: 1 location
1
Fortis Therapy Center
Dripping Springs, Texas, United States, 78620
Actively Recruiting
Research Team
E
Elizabeth Ardolino, PhD, PT
M
Megan Flores, PhD, PT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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