NCT04230278

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

5.2 years

First QC Date

January 13, 2020

Last Update Submit

March 25, 2026

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Change in sitting behavior

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

    Baseline to the end of the intervention, up to 12 months

Secondary Outcomes (4)

  • Change in gross motor skills

    Baseline to the end of the intervention, up to 12 months

  • Change in fine motor skills

    Baseline to the end of the intervention, up to 12 months

  • Change in Cognitive skills

    Baseline to the end of the intervention, up to 12 months

  • Change in Language

    Baseline to the end of the intervention, up to 12 months

Other Outcomes (1)

  • Assessment of Problem Solving in Play

    Baseline to the end of the intervention, up to 12 months

Study Arms (2)

START-Play Intervention

EXPERIMENTAL

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.

Behavioral: START-Play Physical Therapy

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

ACTIVE COMPARATOR

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.

Behavioral: Usual Care Physical Therapy

Interventions

START-Play Physical TherapyBEHAVIORAL

Physical Therapy focused on movement and cognitive skills at the same time

START-Play Intervention
Usual Care Physical TherapyBEHAVIORAL

Physical Therapy focused on movement and reducing impairments

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

Eligibility Criteria

Age8 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Southern California

Los Angeles, California, 90033, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 356490, United States

Location

Related Publications (5)

  • Kretch KS, Dusing SC, Harbourne RT, Hsu LY, Sargent BA, Willett SL. Early Mobility and Crawling: Beliefs and Practices of Pediatric Physical Therapists in the United States. Pediatr Phys Ther. 2024 Jan 1;36(1):9-17. doi: 10.1097/PEP.0000000000001063.

    PMID: 38127897BACKGROUND

  • Kretch KS, Koziol NA, Marcinowski EC, Hsu LY, Harbourne RT, Lobo MA, McCoy SW, Willett SL, Dusing SC. Sitting Capacity and Performance in Infants with Typical Development and Infants with Motor Delay. Phys Occup Ther Pediatr. 2024;44(2):164-179. doi: 10.1080/01942638.2023.2241537. Epub 2023 Aug 7.

    PMID: 37550959BACKGROUND

  • Fiss AL, Hakstad RB, Looper J, Pereira SA, Sargent B, Silveira J, Willett S, Dusing SC. Embedding Play to Enrich Physical Therapy. Behav Sci (Basel). 2023 May 24;13(6):440. doi: 10.3390/bs13060440.

    PMID: 37366692BACKGROUND

  • Dusing SC, Harbourne RT, Hsu LY, Koziol NA, Kretch K, Sargent B, Jensen-Willett S, McCoy SW, Vanderbilt DL. The SIT-PT Trial Protocol: A Dose-Matched Randomized Clinical Trial Comparing 2 Physical Therapist Interventions for Infants and Toddlers With Cerebral Palsy. Phys Ther. 2022 Jul 4;102(7):pzac039. doi: 10.1093/ptj/pzac039.

    PMID: 35421222BACKGROUND

  • Dusing SC, Harbourne RT, Lobo MA, Westcott-McCoy S, Bovaird JA, Kane AE, Syed G, Marcinowski EC, Koziol NA, Brown SE. A Physical Therapy Intervention to Advance Cognitive and Motor Skills: A Single Subject Study of a Young Child With Cerebral Palsy. Pediatr Phys Ther. 2019 Oct;31(4):347-352. doi: 10.1097/PEP.0000000000000635.

    PMID: 31568380BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Stacey Dusing

    University of Southern California Biokinesiology and PT - Motor Development Lab

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor is blinded to group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

March 1, 2021

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)