Actively Recruiting

Phase Not Applicable
Age: 2Years - 6Years
All Genders
ID07184411

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

Age: 2Years - 6Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Treatment

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

Follow-up

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

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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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