CompletedNot Applicable

Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy

United States15 participantsStarted 2022-11-15

Plain-language summary

This research is being done to explore if modified, commercially available, joystick-operated, ride-on-cars can be used to promote bilateral arm function in children with hemiplegic Cerebral Palsy (CP). Specifically, the study evaluates the effects of a 6-week, home-based, child-friendly, innovative program that uses modified, commercially available, joystick-operated, powered ride-on-toys to promote spontaneous affected arm use and function in children with hemiplegic CP.

Who can participate

Age range

3 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Are boys or girls between the ages of 3 - 8 years * Have been diagnosed with hemiplegic Cerebral palsy by a medical doctor with clear asymmetry in upper extremity strength and control, i.e., one upper limb is clearly weaker than the other; * Have had no physical trauma (including surgery) in the past 6 months; * Demonstrate awareness of objects in their environment through their visual system; * Can use their upper extremity or trunk to activate a joystick placed within reachable distance; * Can maintain a supported sitting position for at least 20 minutes Exclusion Criteria: * Have only lower limb involvement * Are capable of using both hands together very well for functional activities; * Age \>8 years or below 3 years of age * Exceed safe weight or height limits of the device; * Have parents who know at the time of the initial contact that they will not be able to complete training and all the posttest sessions

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Affected Arm Movement Control

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Changes in Use of Affected Arm in Functional Activities

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Changes in Habitual Arm Activity on the Affected Side

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Changes in Kinematic Measures of Movement Control on the Affected Arm

Timeframe: at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Treatment Satisfaction

Timeframe: At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)

Perceived Satisfaction With Intervention

Timeframe: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)

Trial details

NCT IDNCT05559320

SponsorUniversity of Connecticut

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-11

Results submitted2025-05-05

View on ClinicalTrials.gov More Hemiplegic Cerebral Palsy trials

Plain-language summary

Who can participate

Age range

3 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Affected Arm Movement Control

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Changes in Use of Affected Arm in Functional Activities

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Changes in Habitual Arm Activity on the Affected Side

Timeframe: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Changes in Kinematic Measures of Movement Control on the Affected Arm

Timeframe: at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Treatment Satisfaction

Timeframe: At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)

Perceived Satisfaction With Intervention

Timeframe: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)