Comparing two physical therapy approaches for young children with cerebral palsy
Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
NA · University of Southern California · NCT04230278
This study is testing two different types of physical therapy for young children with cerebral palsy to see which one helps them develop better motor skills and overall abilities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 8 Months to 24 Months |
| Sex | All |
| Sponsor | University of Southern California (other) |
| Locations | 4 sites (Los Angeles, California and 3 other locations) |
| Trial ID | NCT04230278 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of two physical therapy interventions for children aged 8-24 months who have or are at high risk for cerebral palsy. The first intervention, Sitting Together And Reaching To Play (START-Play), focuses on enhancing sitting, reaching, and motor problem-solving skills to promote overall development. The second intervention, Usual Care Physical Therapy (UCPT), emphasizes advancing motor skills and preventing impairments. By conducting a dose-matched comparison of these interventions, the study seeks to determine which approach is more effective in improving outcomes for these young patients.
Who should consider this trial
Good fit: Ideal candidates are children aged 8-24 months with a diagnosis or clinical signs of cerebral palsy who can prop sit for at least 3 seconds.
Not a fit: Patients with severe medical complications that limit participation or those with progressive disabilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved developmental outcomes for young children with cerebral palsy.
How similar studies have performed: Previous studies have shown promise in similar interventions, but this specific dose-matched comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Dx or clinical signs of cerebral palsy (CP) previously described * Between 8-24 months of age (corrected for prematurity as applicable) at study entry * Able to prop sit for 3 seconds, maintain the head at least to the level of neutral alignment with the trunk supported at the axilla, exhibit some spontaneous movement of the arms and visually focus on a toy or person's face for at least 3 seconds in any position. * Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean) Exclusion Criteria: * Medical complications that severely limit assessments/intervention participation such as severe visual impairment, congenital/orthopedic anomalies that limit sitting or reaching, or uncontrolled seizures. * A child will be excluded if the parents report any of following: 1) disability of a progressive nature such as muscular dystrophy or leukodystrophy; 2) family plans to move out of the local area within one year from the start of the study; 3) major surgery planned that might affect physical performance. 4) genetic conditions that have a similar presentation to intellectual disability or autism.
Where this trial is running
Los Angeles, California and 3 other locations
- University of Southern California — Los Angeles, California, United States (RECRUITING)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
- Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
- University of Washington — Seattle, Washington, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cerebral Palsy