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

Part of paid clinical trials in Storrs, Connecticut.

Sponsor
University of Connecticut
Study ID
NCT06579027
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Children, Only
  • Hemiplegia

Eligibility Criteria

Sex
ALL
Age
3 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • SPEED Training — DEVICE
    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).
  • CRAFT Training — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 26, 2024
Status verified
Jun 2025
Primary completion
Jul 31, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPEED (Strength and Power in upper Extremities through Exploratory Driving)
    Children will receive training focused on improving affected arm function using modified, joystick-operated ride-on toys. The commercial ride-on toys will be modified to allow operation in a single joystick control mode provided on the child's affected side. The manualized SPEED sessions will involve 2 components: (a) Multidirectional navigational games where children will use their affected UE to drive and maneuver the toy and (b) Object-based UE tasks completed at intermediate stops/stations during navigation. Navigational opportunities will encourage children to navigate through paths of different shapes, sizes, and complexity levels (e.g., straight, circle, diamond, slalom, obstacle courses etc.) Object-based tasks will encourage functional UE movement patterns during object interactions such as reaching, throwing, catching, pulling, pushing, lifting, knocking, holding, grasping, opening, closing, release, and manipulation.
  • Active Comparator: CRAFT (Creative Rehabilitation for Arm Functional Training)
    Children will engage in seated creative motor games focused on promoting gross and fine motor UE function. Training sessions will encourage use of the affected UE during unimanual and bimanual activities. Each training session will involve the following components: (a) Stretching exercises and (b) Task-oriented strengthening activities. Stretching exercises will involve range of motion exercises to encourage active warmup of proximal (shoulder, elbow) and distal (wrist, hand) UE muscles and movement dissociation. Task-oriented strengthening will involve use of the affected UE as a mobilizer and a stabilizer during building (e.g., Play-Doh, blocks, puzzles) and art-craft activities (e.g., folding, cutting, pasting, coloring). Task-oriented practice will emphasize skills such as reaching, grasping, release, and manipulation of training supplies.

Primary Outcome Measure

Treatment adherence [ Time Frame: From start to end of the 6-week intervention phase on a weekly basis ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Physical Therapy Program, Department of Kinesiology, University of ConnecticutStorrsConnecticut06269
Sudha M Srinivasan, PhD

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Physical Therapy Program, Department of Kinesiology, University of Connecticut· Storrs, CT

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