Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy

Running, not enrolling · Not applicable

Conditions studied: Cerebral Palsy

In brief

The purpose of the proposed project is to compare the efficacy of two fully developed physical therapy interventions in 8-24 months olds with or at high risk of having Cerebral Palsy (CP). Sitting Together And Reaching To Play (START-Play) targets sitting, reaching and motor-based problem solving in infancy to improve global development. Usual Care Physical Therapy (UCPT) focuses on advancing motor skills and preventing impairments.

Key facts

Study ID

NCT04230278

Run by

University of Southern California

People needed

98

Starts

2021-03-01

Expected to finish

2026-04-30

Last updated by the study team

2026-04-06

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 it is running

• University of Southern California — Los Angeles, California, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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