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N/A N=15 Treatment

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

Hemiplegic Cerebral Palsy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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