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Ride-on Toy Training for Cerebral Palsy

N/A
Recruiting
Research Sponsored by University of Connecticut
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase); during the 6-week intervention phase: early (week 1) and late (week 6) training weeks
Awards & highlights

Summary

This trial is testing if children with hemiplegic CP can use modified, joystick-operated, ride-on-cars to help improve function in their affected arms.

Who is the study for?
This trial is for boys and girls aged 3-8 with hemiplegic Cerebral Palsy, who have noticeable differences in arm strength and control. They should be able to sit supported for 20 minutes, use a joystick with their arm or trunk, and must not have had physical trauma in the last 6 months. Children very capable with both hands or only lower limb involvement are excluded.Check my eligibility
What is being tested?
The study tests if modified joystick-operated ride-on-toys can help children with hemiplegic CP improve the use of their affected arms. Over six weeks at home, kids will participate in a program using these toys designed to encourage spontaneous use of the weaker arm during play.See study design
What are the potential side effects?
Since this intervention involves physical activity through play, potential side effects may include muscle fatigue, frustration if tasks are challenging, or minor injuries from using the ride-on-toys.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase); during the 6-week intervention phase: early (week 1) and late (week 6) training weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase); during the 6-week intervention phase: early (week 1) and late (week 6) training weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
# of training sessions completed assessed using training logs
Upper arm
Changes in habitual arm activity on the affected side
+8 more
Secondary outcome measures
Changes in amount of trainer assistance needed during navigation
Changes in child affect across training sessions
Changes in child attention during training sessions
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Joystick Ride-on-car Navigation TrainingExperimental Treatment2 Interventions
Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,988 Previous Clinical Trials
2,683,508 Total Patients Enrolled
30 Trials studying Cerebral Palsy
8,753 Patients Enrolled for Cerebral Palsy
Virginia Tech (National Pediatric Rehabilitation Resource Center i.e. C-PROGRESS)UNKNOWN
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
648,162 Total Patients Enrolled
11 Trials studying Cerebral Palsy
3,009 Patients Enrolled for Cerebral Palsy

Media Library

Ride-on-toy navigation training Clinical Trial Eligibility Overview. Trial Name: NCT05559320 — N/A
Cerebral Palsy Research Study Groups: Single Joystick Ride-on-car Navigation Training
Cerebral Palsy Clinical Trial 2023: Ride-on-toy navigation training Highlights & Side Effects. Trial Name: NCT05559320 — N/A
Ride-on-toy navigation training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05559320 — N/A
~5 spots leftby Apr 2025