Efficacy of the START-Play Program for Infants With Neuromotor Disorders

NCT02593825 | Completed Results

• 1 other identifier: R324A150103
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to evaluate the efficacy of Sitting Together And Reaching To Play (START-Play), an intervention designed to target sitting, reaching, and motor-based problem solving to improve development and readiness to learn in infants with motor delays or dysfunction. There is limited research examining the efficacy of early physical intervention on infants with neuromotor dysfunction. In addition, most early motor interventions have not been directly linked to learning, despite the research demonstrating an association between motor activity and cognitive skills. START-Play specifically targets motor skills that lead to greater physical exploration, which has been associated with improved problem solving and global development. A randomized controlled trial of START-Play will be conducted across four states to investigate the impact of the intervention on changes over time in sitting and reaching, subsequent changes in global cognitive development, and the mediating influences of motor skill changes and problem solving. The research team will conduct a randomized controlled trial to evaluate the impact of START-Play on motor development, motor problem solving, global development including cognitive problem solving of infants with neuromotor delay and dysfunction. Infants will experience either the intervention or services as usual for 3 months, with following testing at three time points up until 9 months post intervention. The researchers will determine whether the intervention leads to improved sitting and reaching, which leads to improved motor-based problem solving, which leads to improved global development and problem solving.

Conditions

Cerebral Palsy; Developmental Delay; Infant Development

Outcome Measures

Primary Outcomes (1)

• Bayley Scales of Infant Development III

  Bayley Scales of Infant Development III, cognitive scale; raw scores used to reflect change over time and absolute growth (rather than standard scores) Range: Minimum =20 points; Maximum=60 Higher score = better outcome

  Baseline, at end of 3 month intervention, and at 12 months post-baseline

Secondary Outcomes (6)

• Change in Modified Parent Child Interaction-Dyadic Mini Code

  Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline

• Change in Frequency (Number) of Toy Contacts

  Baseline, at end of 3 month intervention, and at 12 months after baseline

• Change in Duration (Time) of Toy Contacts

  Baseline, at end of 3 month intervention, and at 12 months after baseline

• Change in Gross Motor Function Measure, Sitting Subscale

  Baseline, at end of 3 month intervention, and at 12 months after baseline

• Change in Early Problem Solving Indicator (EPSI)

  Baseline, at end of 3 month intervention, and at 6 and 12 months after baseline

Other Outcomes (1)

• Change in Postural Measure of Trunk Angle

  Change over 3 months

Study Arms (2)

START-Play intervention

EXPERIMENTAL

Intervention incorporating cognitive factors and focusing on self-initiated movement toward achievement of skill in sitting and reaching to increase problem-solving skills, which will then improve overall developmental outcomes. Visits to home by physical therapist twice weekly with parent training, for 3 months.

Behavioral: START-Play intervention

Business as Usual

ACTIVE COMPARATOR

Early motor intervention provided as standard treatment in the home for infants with motor dysfunction who are just beginning to sit. Dosage and content of intervention may vary from infant to infant and geographically.

Behavioral: Business as usual

Interventions

START-Play intervention BEHAVIORAL

The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.

Also known as: Perceptual motor early intervention for infants

START-Play intervention

Business as usual BEHAVIORAL

May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training

Also known as: Early intervention, physical therapy

Business as Usual

Eligibility Criteria

• Age: 7 Months - 16 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants enter study between 7-16 months of age, when they are able to prop sit for 3 seconds and maintain their head at least to the level of neutral alignment with their trunk.
• Gross motor delay as reflected in the Bayley III motor subtest \>1.0 Standard Deviation below the mean.
• Neuromotor disorder such as cerebral palsy (CP), or at risk for CP because of extreme prematurity or brain damage that occurred at or around birth, or infants with motor delay of an unspecified origin (no clear diagnosis, but delay as above) -• Minimal movement requirements/Indicators of readiness for change: Sits with support of arms for 3 seconds after being placed. Exhibits at least some spontaneous movement of arms.

You may not qualify if:

• Medical complications that severely limit participation in assessments and intervention such as severe visual and congenital/genetic anomalies, uncontrolled seizure disorder.
• Diagnosis other than an unchanging neuromotor disorder (examples: autism, Down syndrome, spinal cord injury, acquired head injury, muscle disorder).
• A child will be excluded if the parents report any of following: 1) if the child has a disability of a progressive nature such as muscular dystrophy; 2) if the child's family plans to move out of the local area within one year from the start of the study; 3) if the child has major surgery planned that might affect physical performance.

Sponsors & Collaborators

• Duquesne University: lead
• University of Delaware: collaborator
• Virginia Commonwealth University: collaborator
• University of Washington: collaborator
• University of Nebraska Lincoln: collaborator

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

Related Publications (6)

• Harbourne RT, Dusing SC, Lobo MA, Westcott-McCoy S, Bovaird J, Sheridan S, Galloway JC, Chang HJ, Hsu LY, Koziol N, Marcinowski EC, Babik I. Sitting Together And Reaching To Play (START-Play): Protocol for a Multisite Randomized Controlled Efficacy Trial on Intervention for Infants With Neuromotor Disorders. Phys Ther. 2018 Jun 1;98(6):494-502. doi: 10.1093/ptj/pzy033.

  PMID: 29767802 BACKGROUND

• Molinini R, Stuyvenburg C, Koziol NA, Harbourne RT, Lobo MA, Willett SL, Bovaird JA, Marcinowski E, Price SK, Shall M, Chu VW, Dusing SC. Developmental Trajectories of Emotional Availability Differ Between Dyads With Children With and Without Motor Delay. Infancy. 2025 May-Jun;30(3):e70027. doi: 10.1111/infa.70027.

  PMID: 40537937 DERIVED

• Cunha AB, Babik I, Choi D, Koziol N, Harbourne RT, Dusing SC, McCoy SW, Willett SL, Bovaird JA, Lobo MA. The impact of severity of motor delay, timing of task mastery, and START-play intervention on the development of means-end problem solving in young children. Braz J Phys Ther. 2024 Jan-Feb;28(1):100590. doi: 10.1016/j.bjpt.2024.100590. Epub 2024 Feb 9.

  PMID: 38359542 DERIVED

• Koziol NA, Butera CD, Kretch KS, Harbourne RT, Lobo MA, McCoy SW, Hsu LY, Willett SL, Kane AE, Bovaird JA, Dusing SC. Effect of the START-Play Physical Therapy Intervention on Cognitive Skills Depends on Caregiver-Provided Learning Opportunities. Phys Occup Ther Pediatr. 2022;42(5):510-525. doi: 10.1080/01942638.2022.2054301. Epub 2022 Mar 29.

  PMID: 35350970 DERIVED

• Harbourne RT, Dusing SC, Lobo MA, McCoy SW, Koziol NA, Hsu LY, Willett S, Marcinowski EC, Babik I, Cunha AB, An M, Chang HJ, Bovaird JA, Sheridan SM. START-Play Physical Therapy Intervention Impacts Motor and Cognitive Outcomes in Infants With Neuromotor Disorders: A Multisite Randomized Clinical Trial. Phys Ther. 2021 Feb 4;101(2):pzaa232. doi: 10.1093/ptj/pzaa232.

  PMID: 33382406 DERIVED

• Marcinowski EC, Tripathi T, Hsu LY, Westcott McCoy S, Dusing SC. Sitting skill and the emergence of arms-free sitting affects the frequency of object looking and exploration. Dev Psychobiol. 2019 Nov;61(7):1035-1047. doi: 10.1002/dev.21854. Epub 2019 Apr 22.

  PMID: 31012090 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Learning Disabilities

Interventions

Commerce; Early Intervention, Educational; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Technology, Industry, and Agriculture; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Regina Harbourne, Primary Investigator
• Organization: Duquesne University

harbourner@duq.edu

4026570538

Study Officials

• Regina T Harbourne, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

• Sarah W McCoy, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Michele A. Lobo, PhD

  University of Delaware

  PRINCIPAL INVESTIGATOR

• Stacey C. Dusing, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 2, 2015
• Study Start: January 1, 2016
• Primary Completion: June 1, 2020
• Study Completion: June 12, 2022
• Last Updated: March 18, 2024
• Results First Posted: September 1, 2020

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)