N/A
N=15
Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy
Hemiplegic Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT05559320 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Affected Arm Movement Control — 74.9; 78.3; 83.8 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ride-on-toy navigation training (Device); Upper extremity functional training (Behavioral)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- University of Connecticut
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Affected Arm Movement Control |
74.9; 78.3; 83.8 | — |
| PRIMARY Changes in Use of Affected Arm in Functional Activities |
52.3; 53.3; 60.7 | — |
| PRIMARY Changes in Habitual Arm Activity on the Affected Side |
48.4; 50.9; 50.4 | — |
| PRIMARY Changes in Kinematic Measures of Movement Control on the Affected Arm |
113.69; 123.93; 112.68; 132.59; 58.72; 69.78 | — |
| PRIMARY Treatment Satisfaction |
3.7; 3.9 | — |
| PRIMARY Perceived Satisfaction With Intervention |
12; 15 | — |
| PRIMARY Ease of Implementation of Training |
14; 9 | — |
| PRIMARY Changes in Treatment Fidelity Across Training Weeks |
95.1; 96.1; 95.6 | — |
| PRIMARY Changes in Toy Use (in Minutes/Week) Across Training Weeks |
34.3; 41.5; 44.2; 40.4; 38.5; 60.4 | — |
| PRIMARY # of Training Sessions Completed Assessed Using Training Logs |
98.33 | — |
| SECONDARY Changes in Parent-rated Scores on Functional Use of the Affected Arm |
0.1; 0.5; 1.2 | — |
| SECONDARY Changes in Amount of Trainer Assistance Needed During Navigation |
73.4; 88.7; 95.4 | — |
| SECONDARY Changes in Child Attention During Training Sessions |
80.7; 83.9; 83.4 | — |
| SECONDARY Changes in Child Affect Across Training Sessions |
98.1; 99.3; 98.9 | — |
| SECONDARY Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions |
31.2; 27.7; 14.8 | — |
| SECONDARY Changes in Rates of Obstacle Contacts Across Testing Sessions |
1.4; 1.8; 0.5 | — |
| SECONDARY Changes in Rates of Path Deviations Across Testing Sessions |
2.2; 2.0; 1.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05559320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.