ACTIVE_NOT_RECRUITING

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

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Conditions

Cerebral Palsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-03-01
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04230278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Months to 24 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Dx or clinical signs of cerebral palsy (CP) previously described
  2. * Between 8-24 months of age (corrected for prematurity as applicable) at study entry
  3. * 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.
  4. * Gross motor delay with a Bayley IV gross motor subscale score less than 5.5 (1.5 standard deviation below mean)
  1. * Medical complications that severely limit assessments/intervention participation such as severe visual impairment, congenital/orthopedic anomalies that limit sitting or reaching, or uncontrolled seizures.
  2. * 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.

Contacts and Locations

Principal Investigator

Stacey Dusing
PRINCIPAL_INVESTIGATOR
University of Southern California Biokinesiology and PT - Motor Development Lab

Study Locations (Sites)

University of Southern California
Los Angeles, California, 90033
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States
University of Washington
Seattle, Washington, 356490
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Stacey Dusing, PRINCIPAL_INVESTIGATOR, University of Southern California Biokinesiology and PT - Motor Development Lab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-03-01
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2021-03-01
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cerebral Palsy