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Ride-on Toy Training for Cerebral Palsy

N/A

Waitlist Available

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

No Placebo-Only Group

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.

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.

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 weeks3 visits

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

# of training sessions completed assessed using training logs

Upper arm

Changes in habitual arm activity on the affected side

+8 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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