A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia (NCT06579027) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia
United States30 participantsStarted 2024-09-26
Plain-language summary
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.
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:
* Boys and girls between the ages of 3 - 8 years
* Diagnosed with hemiplegia by a medical doctor with clear asymmetry in upper extremity strength and control (i.e., one upper limb is clearly weaker than the other)
* Can maintain a supported sitting position for at least 15 minutes
Exclusion Criteria:
* Only lower limb involvement
* Recent history (within past 6 months) of trauma or surgery or Botox
* Uncorrected blindness/profound visual impairment
* Fixed deformities at wrist or hand
* No active control in affected UE
* Inability to follow 2-step directions
* Weight \> 150 lbs.
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.
1This trial uses ride-on toys to encourage children with hemiplegia to use their affected arm — can you help me understand how that kind of play-based approach might work for my child's specific level of arm function?
2Since this study is in Phase NA, meaning it seems to be focused on whether the program works in practice and whether families stick with it, what do we actually know so far about whether ride-on toy therapy is safe and beneficial for children with cerebral palsy and hemiplegia?
3The trial is measuring things like treatment adherence and family satisfaction alongside arm function — what would participation actually look like for us day-to-day, and is the time commitment realistic given our schedule?
4The study tracks changes in hand grip strength and how much my child uses their affected arm in real activities — are there other therapies or interventions already available that target the same goals, and how would you compare them to what this trial is offering?
5Would my child's current therapy plan need to change or pause if we considered joining this trial, and how would you make sure their overall progress stays on track?
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
1
Treatment adherence
Timeframe: From start to end of the 6-week intervention phase on a weekly basis
2
Treatment retention
Timeframe: From date of randomization to date of the final data collection visit with the last participant, assessed over 24 months
3
Treatment satisfaction
Timeframe: At 8 weeks (i.e., at the posttest visit conducted following completion of the 6-week intervention phase)
4
Changes in use of affected arm in functional activities
Timeframe: Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)
5
Changes in hand grip strength
Timeframe: Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of the intervention phase)