Cerebral Palsy (CP)ENGAGE-CPNCT07184411
Activities-based Locomotor Training in Children With Cerebral Palsy
A study testing Activities-based locomotor training and physical therapy in people with Cerebral Palsy (CP), run by Baylor University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Activities-based locomotor training and physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2026to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- • Surgery or botulinum toxin injections in the previous 6 months;
- Uncontrolled epilepsy; and
- Uncontrolled cardiovascular disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megan Flores, PhD, PT contact
United States1 site, 1 recruiting
- Recruiting
Fortis Therapy Center
Dripping Springs, Texas, 78620
Elizabeth M Ardolino, PhD, 215-605-9319, liz_ardolino@baylor.edu
Megan Flores, PhD, 512-529-4421, megan_flores@baylor.edu
About this study
Official title: Efficacy of 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Activities-based locomotor training, physical therapy
- Keywords
- Cerebral Palsy, Locomotor Training, Physical Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activities-based locomotor trainingOther
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 therapyOther
In this intervention, the child will attend their usual physical therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Activities-based locomotor training (AB-LT) | Experimental | 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. Receives: Other: Activities-based locomotor training |
| Usual care | Active comparator | 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. Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM-66)
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).
Measured: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.
Secondary outcomes (2)
functional near infrared spectroscopy (fNIRS)
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.
Measured: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.
Child Engagement in Daily Life (CEDL)
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.
Measured: 4 testing sessions: Baseline, end of week 3, end of week 4, end of week 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start11 Jan 2026
- Primary completion1 May 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Elizabeth Ardolino, PhD, PT, Principal investigator, Baylor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184411
- Sponsor's protocol ID
- 2245497
- Other IDs
- 1R15HD119622-01
- Acronym
- ENGAGE-CP
- Status last verified
- Aug 2026
- First submitted
- 11 Sep 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified raw data includes child functional near infrared spectroscopy (fNIRS), child functional gross motor ability levels obtained from the Gross Motor Function Measure (GMFM-66), Child Engagement in Daily Life survey data collected from primary caregivers, and parent-reported demographic information. Analyzed data that will be shared at the conclusion of the project includes statistical models, and descriptive analysis.