19 Participants Needed

Activities-Based Locomotor Training for Cerebral Palsy

(ENGAGE-CP Trial)

MF
EA
Overseen ByElizabeth Ardolino, PhD, PT
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Baylor University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an Activities-Based Locomotor Training (AB-LT) program can improve the lives of young children with Cerebral Palsy who cannot walk independently. The researchers aim to determine if this intensive program, which includes treadmill walking and play-based therapy, is more effective than the usual care these children receive. Children who cannot walk as their primary means of mobility and can hold their head up for a few seconds may be suitable candidates for the trial. Participants must be willing to travel to Dripping Springs, Texas, and commit to a 7-week study period, including 3 weeks of intensive therapy sessions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance therapeutic options for children with Cerebral Palsy.

What prior data suggests that this Activities-Based Locomotor Training is safe for children with Cerebral Palsy?

Research has shown that Activities-Based Locomotor Training (AB-LT) is generally safe for children with cerebral palsy. In past studies, children participated in intensive sessions that included walking and standing in a harness on a treadmill, along with play-based physical therapy. Trained physical therapists supervised these activities.

The studies found no major negative effects from this training, suggesting that AB-LT is a safe option for children. Since this treatment is non-invasive and similar to structured physical therapy, it is less likely to cause harm. However, like any physical activity, children might experience some discomfort or tiredness after sessions.

Overall, the available evidence supports that AB-LT is a safe and promising way to help improve motor skills in children with cerebral palsy.12345

Why are researchers excited about this trial?

Activities-based locomotor training (AB-LT) is unique because it combines treadmill walking with play-based physical therapy in an intensive, structured program. Unlike standard treatments for cerebral palsy, which might involve varied and less frequent physical, occupational, or speech therapies, AB-LT offers a concentrated approach specifically designed to enhance motor skills through repetitive activity. Researchers are excited about AB-LT because it could potentially lead to quicker improvements in mobility and strength by providing consistent, focused training that targets walking and standing abilities in a supportive harness environment.

What evidence suggests that Activities-Based Locomotor Training is effective for improving outcomes in children with Cerebral Palsy?

Research shows that Activities-Based Locomotor Training (AB-LT), which participants in this trial may receive, can improve movement in children with cerebral palsy (CP). Studies have found that this intensive program enhances skills like walking and standing. The program includes fun, play-based physical therapy, helping children learn and adapt through enjoyable activities. Early results suggest that AB-LT can reduce disability and improve the quality of life for children with CP who cannot walk. By boosting neuroplasticity, the brain's ability to change and adapt, this approach offers a promising path for rehabilitation.12346

Who Is on the Research Team?

EA

Elizabeth Ardolino, PhD, PT

Principal Investigator

Baylor University

Are You a Good Fit for This Trial?

This trial is for young non-ambulatory children with Cerebral Palsy who can hold their head up with support, cannot walk more than 10 feet without help, and are willing to commit to a 7-week study. They must attend therapy in Texas for 3 hours a day, five days a week for three weeks.

Inclusion Criteria

My child cannot walk or uses other ways to move around.
My child can hold their head up for 5 seconds with support.
My child can attend a 3-week therapy program in Texas for 15 hours a week.
See 1 more

Exclusion Criteria

Child must not have uncontrolled epilepsy
My child hasn't had surgery or botox injections in the last 6 months.
My child does not have any heart conditions that aren't under control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 3-week intensive Activities-Based Locomotor Training (AB-LT) program, consisting of 3 hours per day, 5 days a week

3 weeks
15 visits (in-person)

Usual Care

Participants continue their usual therapy schedule, which may include physical therapy, occupational therapy, and/or speech language pathology

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at the end of weeks 3, 4, and 7

4 weeks
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Activities-based Locomotor Training
Trial Overview The trial tests an Activities-Based Locomotor Training (AB-LT) program against usual care to see if it improves life quality and functional outcomes by enhancing neuroplasticity and motor learning in children with CP.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Activities-based locomotor training (AB-LT)Experimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor University

Lead Sponsor

Trials
65
Recruited
67,600+

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

Collaborator

Trials
2,103
Recruited
2,760,000+

Citations

Activities-based Locomotor Training in Children With ...Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately ...
Efficacy of an activities-based locomotor training program ...This project aims to evaluate the efficacy of an Activities- Based Locomotor Training (AB-LT) program for young non-ambulatory children with CP, addressing the ...
Activities-based Locomotor Training Program Versus ...The purpose of this study is to investigate the impact of an intensive activities-based locomotor training program as compared to traditional physical therapy ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40982378/
Functional and Neurophysiological Changes After ...Conclusions: The 3-week AB-LT regimen is a short duration, high-intensity program with the potential to benefit children with CP. Keywords: ...
Activities-based Locomotor Training in Children With Cerebral ...Results from this research will lead to more effective, individualized therapies that improve motor function, reduce disability, and ultimately ...
Activities-based Locomotor Training Program Versus ...Outcome measures will be obtained 4 times, occurring every 3 weeks over a period of 9 weeks: pre-intervention, post-intervention, pre-traditional therapy, and ...
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