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

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

Interventions

BEHAVIORAL

START-Play intervention

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.

BEHAVIORAL

Business as usual

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

Sponsors & Collaborators

• University of Delaware

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• University of Washington

  collaborator OTHER

• University of Nebraska Lincoln

  collaborator OTHER

• Duquesne University

  lead OTHER

Principal Investigators

• Regina T Harbourne, PhD · Duquesne University

• Sarah W McCoy, PhD · University of Washington

• Michele A. Lobo, PhD · University of Delaware

• Stacey C. Dusing, PhD · Virginia Commonwealth University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

7 Months

Max Age

16 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2020-06-01

Completion

2022-06-12

Countries

• United States

Study Locations