Efficacy of a Physical Therapy Intervention Targeting Sitting and Reaching for Young Children With Cerebral Palsy (SIT-PT)

University of Southern California

Status: Active, not recruiting

Conditions: Cerebral Palsy

Treatments: Behavioral: Usual Care Physical Therapy; Behavioral: START-Play Physical Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04230278

HM20016342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 8 to 24 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

START-Play Intervention

Experimental group

Description:

Sitting Together And Reaching to Play is an intervention designed to work on motor-based problem-solving. Thus the activities keep thinking skills at the forefront while also working on advancing motor skills. When initially developed to work with children who were emerging sitters the motor tasks focused on sitting and reaching resulting in the name.

Treatment:

Behavioral: START-Play Physical Therapy

Movement, Orientation, Repetition, and Exercise (MORE-PT) - Usual Care Physical Therapy

Active Comparator group

Description:

This intervention was based on the observations of usual care from a previous study. Key principles included the use of Movement, Orientation, Repetition, and Exercise thus the intervention name was changed to MORE-PT before enrollment started. This reduced bias as the therapists and families were not informed this was usual care which could have biased them.

Treatment:

Behavioral: Usual Care Physical Therapy