Play-Based Training for Childhood Hemiplegia

Overseen By Sudha M Srinivasan, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Connecticut

Disqualifiers: Lower limb involvement, Recent trauma, Blindness, Fixed deformities, No active control, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 6 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two play-based training programs, SPEED and CRAFT, to improve arm function in young children with hemiplegia, a condition where one side of the body is weaker. SPEED uses joystick-operated ride-on toys to encourage movement, while CRAFT involves creative motor games focusing on both gross and fine motor skills. The trial aims to assess the effectiveness of these programs and family satisfaction with them. Children aged 3 to 8 years with noticeable weakness in one arm and the ability to sit with support for at least 15 minutes may be suitable candidates. As an unphased trial, this study provides families with a unique opportunity to contribute to innovative research that could enhance therapeutic options for children with hemiplegia.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these play-based training programs are safe for children with hemiplegia?

Research has shown that joystick-operated ride-on toys in therapy can improve children's motor skills. Other studies have used these toys safely, with no serious side effects reported. However, limited safety data exists for children with disabilities using these modified toys. Some studies have mentioned toy-related injuries like falls, which is important to consider.

For the creative motor games, activities such as stretching and task-oriented exercises are generally safe and aim to improve arm movements and strength. No specific safety concerns have been reported for these activities.

Overall, both training methods appear well-tolerated. While some risk exists, it mostly involves common toy-related injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Play-Based Training for Childhood Hemiplegia because it uses innovative, engaging methods to improve upper extremity function in children. Unlike traditional physical therapy, which often involves repetitive exercises, the SPEED approach uses joystick-operated ride-on toys to make therapy fun and interactive. This method encourages children to use their affected arm in a playful setting, promoting natural movement through games and obstacle courses. The CRAFT method complements this by focusing on creative motor games and art activities, which help strengthen the arm through tasks like building and crafting. These approaches aim to make rehabilitation more engaging, which could lead to better participation and outcomes for young patients.

What evidence suggests that these play-based training programs could be effective for childhood hemiplegia?

This trial will compare two different play-based training approaches for childhood hemiplegia. One arm of the trial uses joystick-operated ride-on toys, which studies have shown can improve arm function in children. These toys encourage the use of the affected arm through navigation games and tasks involving reaching and grasping. Research indicates they are fun and engaging therapy tools. The other arm of the trial involves creative motor games. Research shows that activities like building with blocks or doing art projects can enhance both large and small muscle skills. These activities help children use their affected arm more in everyday tasks. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for children aged 3 to 8 with hemiplegia, often due to cerebral palsy. It's designed to help improve arm function through play-based training programs at home or in community settings. The child and caregiver will work together with researchers.

Inclusion Criteria

My child is between 3 and 8 years old.

I have been diagnosed with hemiplegia, and one of my arms is clearly weaker than the other.

I can sit up with support for at least 15 minutes.

Exclusion Criteria

I am legally blind or have severe vision loss.

My condition only affects my lower limbs.

I have had surgery, trauma, or Botox in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (phone)

Pretest

Standardized assessments to evaluate the child's ability to use their affected arm for different functional activities

1 week

1 visit (in-person)

Treatment

Participants receive either SPEED or CRAFT training for 6 weeks with research team visits and caregiver-led sessions

6 weeks

12 visits (in-person by research team), 12 sessions (caregiver-led)

Posttest

Assessments and questionnaires repeated to evaluate changes in arm function and treatment satisfaction

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in arm function and treatment retention

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Ride-on Toys

Trial Overview

The study compares two types of training: SPEED Training uses joystick-operated powered ride-on toys, while CRAFT Training involves creative activities for upper extremity improvement. Researchers want to see which program better enhances arm motor skills and daily use of the affected arm.

How Is the Trial Designed?

Group I: SPEED (Strength and Power in upper Extremities through Exploratory Driving) Experimental Treatment 1 Intervention

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.

Group II: CRAFT (Creative Rehabilitation for Arm Functional Training) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Connecticut

Lead Sponsor

Trials

194

Recruited

162,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

The study will evaluate a 6-week home-based ride-on-toy navigation training (RNT) program for 15 children aged 3 to 8 years with unilateral cerebral palsy (UCP), aiming to improve upper extremity function when combined with conventional therapy.

The RNT program is expected to be feasible and acceptable, with assessments planned to measure improvements in unimanual and bimanual function, as well as child engagement and motivation during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP). Shahane, V., Kumavor, P., Morgan, K., et al.[2023]

Toy-related injuries, especially from ride-on toys, have significantly increased over the past decade, with children with disabilities being at a higher risk for these injuries.

There is a notable lack of safety studies specifically addressing the risks of ride-on toys for children with disabilities, highlighting the need for improved research methods, such as computer simulations, to better understand and mitigate these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric safety: review of the susceptibility of children with disabilities to injuries involving movement related events. Fraser, A., Doan, D., Lundy, M., et al.[2022]

A 3-week training program using joystick-operated ride-on toys was enjoyable for children with hemiplegic cerebral palsy, as reported by children, caregivers, and clinicians, indicating high acceptance of the intervention.

Caregivers and clinicians observed increased motivation in children to use their affected upper extremity and perceived improvements in movement control and function, suggesting potential efficacy of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Using Joystick-Operated Ride-on-Toys to Promote Upper Extremity Function in Children With Cerebral Palsy: A Pilot Study. Amonkar, N., Kumavor, P., Morgan, K., et al.[2022]

A study involving 20 children aged 5-11 showed that different toys and computer games can significantly affect wrist range of motion and motion frequency during play, which is important for therapy in children with hemiplegic cerebral palsy.

Despite variations in wrist movement, all toys and games were equally enjoyable for the children, suggesting that engagement in play can be a motivating factor for therapy and may enhance rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wrist range of motion and motion frequency during toy and game play with a joint-specific controller specially designed to provide neuromuscular therapy: A proof of concept study in typically developing children. Crisco, JJ., Schwartz, JB., Wilcox, B., et al.[2018]

Modified ride-on cars can significantly benefit young children with mobility limitations by promoting social-emotional development and mobility skills, as evidenced by a review of 13 case studies and one case-controlled study.

The research highlights the need for further studies using reliable outcome measures to better understand the developmental impacts of modified ride-on cars across various domains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modified Ride-on Cars as Early Mobility for Children with Mobility Limitations: A Scoping Review. James, D., Pfaff, J., Jeffries, LM.[2020]

A study involving 10 children with hemiplegia demonstrated that performance measures from a custom therapy video game can effectively indicate upper extremity motor function, correlating well with standardized assessments.

The findings suggest that this low-cost motion capture system could be a valuable tool for monitoring motor function and progress in therapy, enhancing the treatment of pediatric hemiplegia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concurrent Validity of Measures of Upper Extremity Function Derived from Videogame-Based Motion Capture for Children with Hemiplegia. Adams, RJ., Lunsford, CD., Stevenson, RD., et al.[2023]

In a study involving 11 children with hemiplegic cerebral palsy, joystick-operated ride-on toys (ROTs) were found to improve upper extremity function, with small-to-medium enhancements in standardized evaluation scores after three weeks of training.

The majority of participants (90-100%) showed significant increases in the use of their affected arm during activities, indicating that ROTs can be effective and motivating tools to complement traditional therapies like constraint-induced movement therapy (CIMT).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes Associated with a Single Joystick-Operated Ride-on-Toy Navigation Training Incorporated into a Constraint-Induced Movement Therapy Program: A Pilot Feasibility Study. Srinivasan, S., Amonkar, N., Kumavor, P., et al.[2023]

The introduction of a joystick-based proportional control system in modified ride-on toy cars allows young children with severe disabilities to have greater control over their movement, enhancing their ability to play and interact with peers.

In a study involving 7 children under the age of six, all participants successfully self-initiated the activation of the modified cars, demonstrating the effectiveness of these enhancements in promoting self-directed mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced Steering and Drive Adaptations of Modified Ride-On Toy Cars for Improved Directional Control in Very Young Children With Severe Multiple Developmental Impairments. Aceros, J., Lundy, M.[2022]

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Play-Based Training for Childhood Hemiplegia

There is limited safety data specifically for children with disabilities using modified ride-on toys, but toy-related injuries, especially from falls and ...