Activities-based locomotor training for young children with cerebral palsy

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

This study will test whether a 3-week activities-based locomotor training program can help young non-ambulatory children with cerebral palsy improve movement and daily activities compared with usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 19 (estimated)
• Ages: 2 Years to 6 Years
• Sex: All
• Sponsor: Baylor University (other)
• Locations: 1 site (Dripping Springs, Texas)
• Trial ID: NCT07184411 on ClinicalTrials.gov

What this trial studies

The trial compares an intensive Activities-Based Locomotor Training (AB-LT) program to usual care in young, non-ambulatory children with cerebral palsy, targeting body structures, activities, and participation using the ICF framework. Children receive AB-LT at a clinic for 3 hours per day, 5 days per week, over a 3-week period and commit to 7 weeks of total study participation while continuing usual care off-treatment. The approach emphasizes repetitive, task-specific practice to drive neuroplasticity and motor learning with the goal of improving motor function and quality of life. Outcomes will include functional mobility and participation measures relevant to daily activities.

Who should consider this trial

Good fit: Ideal candidates are young non-ambulatory children with cerebral palsy who can hold their head upright for at least 5 seconds when supported, have no recent surgery or botulinum toxin in the past 6 months, and can commit to intensive clinic sessions in Dripping Springs, Texas.

Not a fit: Children who already use walking as their primary mobility, have uncontrolled epilepsy or cardiovascular disease, recent surgeries or botulinum toxin injections within 6 months, or who cannot tolerate intensive therapy are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the intervention could improve motor function and daily participation for non-ambulatory children with cerebral palsy, potentially reducing long-term disability and care needs.

How similar studies have performed: Prior intensive locomotor and treadmill-based programs have shown functional improvements in some children with cerebral palsy, but AB-LT in very young non-ambulatory children is relatively novel and less extensively tested.

Eligibility criteria

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

Where this trial is running

Dripping Springs, Texas

• Fortis Therapy Center — Dripping Springs, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Elizabeth Ardolino, PhD, PT — Baylor University
• Study coordinator: Elizabeth Ardolino, PhD, PT

Conditions: Cerebral Palsy, Locomotor Training, Physical Therapy