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NCT Number: NCT07184411

Activities-based Locomotor Training in Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gross Motor Function Measure (GMFM-66)

    Time frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.

    The GMFM-66 is the gold standard for measuring gross motor function in children with CP. A child's capabilities are scored across five dimensions (66 items), including Lying and Rolling (Dimension A), Sitting (Dimension B), Crawling and Kneeling (Dimension C), Standing (Dimension D), and Walking, Running, and Jumping (Dimension E).

Secondary outcomes

  1. functional near infrared spectroscopy (fNIRS)

    Time frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.

    functional near-infrared spectroscopy (fNIRS) is a non-invasive neuroimaging technique that uses infrared light to assess hemodynamic shifts in the prefrontal cortex during movement. It involves wearing a lightweight neoprene headband that contains sensors.

  2. Child Engagement in Daily Life (CEDL)

    Time frame: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.

    The Child Engagement in Daily Life (CEDL) is a survey completed by parents or caregivers of children, 18 months through 12 years of age. The CEDL describes a child's participation in daily activities such as interactions with others, play, and self-care.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Ardolino, PhD, PT

CONTACT

[email protected]

215-605-9319

Megan Flores, PhD, PT

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Baylor University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Efficacy of Activities-based Locomotor Training in Children With Cerebral Palsy.

Acronym: ENGAGE-CP

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2025
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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