Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy (START-Play-CP)

• ClinicalTrials.gov Identifier: NCT04230278
• Recruitment Status: Recruiting
• First Posted: January 18, 2020
• Last Update Posted: April 13, 2021
• Sponsor: University of Southern California
• Information provided by (Responsible Party): Stacey Dusing, University of Southern California

Tracking Information

• First Submitted Date: January 13, 2020
• First Posted Date: January 18, 2020
• Last Update Posted Date: April 13, 2021
• Actual Study Start Date: March 1, 2021
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 13, 2020)

Change in sitting behavior [ Time Frame: Baseline to the end of the intervention, up to 12 months ]

Sitting will be assessed using the sitting scale of the Gross Motor Function Measure (GMFM-88)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 13, 2020)

change in gross motor skills [ Time Frame: Baseline to the end of the intervention, up to 12 months ]

Gross motor skills will be assessed using the gross motor subtest of the Bayley Scales of Infant and Toddler Development, third edition (Bayley-III).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
• Official Title: Evaluation of the Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy
• Brief Summary: 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.

Detailed 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. The project builds on a nearly complete clinical trial evaluating the efficacy of the START-Play intervention compared to a non-dose matched comparison group. The proposed study directly addressed the need for a dose-matched clinical trial to consider the impact of dose of intervention on efficacy. A direct comparison of START-Play with the dose matched (24 visits in 3 months) UCPT provided in the same environment (homes) and provided by licensed physical therapists will allow for a direct comparison of the efficacy of interventions based on two different set of key principles.

START-Play is based on developmental and basic science, motor learning, and neuroplasticity, in addition to our extensive preliminary efficacy data. START-Play has been fully described with a protocol manual, training documents, and fidelity measures. The UCPT intervention is based on videotaped session of the comparison group community based intervention sessions and parent report for the ongoing clinical trial. A fidelity measure used the previous research quantifies differences in the focus of these interventions and will be used to maintain adherence to both intervention groups. Three sites in different regions of the United States will recruit from local intervention and medical centers for a total of 150 infants with or at high risk of having cerebral palsy between ages 4-24 months of age, when they show readiness skills for early sitting and reaching. Risk for CP will be based on the early detection guidelines and all outcome measures are included in the NIH supported Common Data Elements for Cerebral Palsy. Each infant will be randomized into a group and will receive the START-Play or the UCPT intervention for 3 months, with follow up extending for 12 months from baseline.

The primary objectives examine change over time in sitting gross motor and cognitive development.

Differences in outcomes between the two intervention groups will be examined. In addition, we will begin to identify predictors of response to developmental motor interventions by evaluating the relationship between intervention outcomes and 1) infant and family characteristics, 2) presence of white matter, cerebellar, basal ganglion, or gray matter injury.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cerebral Palsy

Intervention

• Behavioral: START-Play Physical Therapy
  Physical Therapy focused on movement and cognitive skills at the same time
• Behavioral: Usual Care Physical Therapy
  Physical Therapy focused on movement and reducing impairments

Study Arms

• Experimental: START-Play Intervention
  Intervention: Behavioral: START-Play Physical Therapy
• Active Comparator: Usual Care Physical Therapy
  Intervention: Behavioral: Usual Care Physical Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 13, 2020): 150
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2025
• Estimated Primary Completion Date: July 2025 (Final data collection date for primary outcome measure)

Eligibility 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 III 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Months to 24 Months (Child)
• Accepts Healthy Volunteers: No
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04230278
• Other Study ID Numbers: HM20016342
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Stacey Dusing, University of Southern California
• Study Sponsor: University of Southern California
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Southern California
• Verification Date: April 2021