A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia

Summary

The purpose of this study is to assess the feasibility and utility of 2 types of play-based training programs co-delivered by researchers and caregivers within home/community settings to promote arm function among 3-to-8-year-old children with hemiplegia. Specifically, investigators will assess the feasibility of implementation and acceptance/satisfaction associated with a researcher-caregiver co-delivered community-based training program involving either joystick-operated powered ride-on toys (SPEED training) or creative upper extremity training (CRAFT training).

The investigators will also compare the effects of these 2 types of training programs on children's arm motor function and spontaneous use of their affected arm during daily activities.

Conditions

• Hemiplegia
• Cerebral Palsy
• Children, Only

Interventions

DEVICE

SPEED Training

Children will use ride-on toys controlled using their affected arm to navigate through their environment and complete playful theme-based challenges. Children will use their affected UE during navigation to start and stop the toy, move steadily forward and backward, turn to the right and left, perform 180° and 360° turns to either side, and avoid obstacles. Children will complete object-based UE tasks requiring gross and fine motor control at intermediate stops during navigation. Navigational tasks will be progressed by increasing complexity of paths (straight to slalom paths needing more directional changes), spaces (wide to narrow spaces), and precision (obstacle courses and mazes requiring skillful navigation, motor planning, and route finding). Object-based tasks will be progressed in terms of force requirements (small to large forces), range of motion (near to far reaches), precision (manipulation of large to small objects), and speed of movements (slow to fast).

BEHAVIORAL

CRAFT Training

Children will engage in predominantly seated activities based on conventional occupational therapy to promote unimanual and bimanual UE function. Training sessions will be based on playful child-friendly themes (e.g., dinosaurs, space exploration, aquatic theme, etc.) and all training activities will incorporate the session theme. Activities will involve practice of functional gross and fine motor UE movement patterns that children typically use during daily life. Training will emphasize the use of the affected UE in different roles (i.e., stabilizer, mobilizer, and active and passive assist) during warm-up, building, and art-craft activities. The training will be progressed in terms of forces needed, range of motion, precision, and movement speed.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• University of Connecticut

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-26

Primary Completion

2026-07-31

Completion

2026-09-01

FDA Device

Yes

Countries

• United States

Study Locations