Adults 3 to 8, any sex, with Hemiplegic Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change in Affected Arm Movement ControlPrimary· Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
The Quality of Upper Extremity Skills Test (QUEST) is a criterion-referenced, valid, and reliable measure for use between 18 months-12 years to assesses quality of UE function in 4 domains: dissociated movement, grasp, protective extension, and weight bearing. The tool includes 36 items that evaluate movement patterns and hand function in children with CP and are scored on a dichotomous scale. Scores for each sub-domain and the total score are calculated as percentages. The total QUEST score was calculated by summing scores for each sub-domain tested divided by the total number of sub-domains
Baseline
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
74.9
± 3.1
6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
78.3
± 3.5
12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
83.8
± 2.2
Changes in Use of Affected Arm in Functional ActivitiesPrimary· Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
The Shriner's Hospital Upper Extremity Evaluation (SHUEE) is a video-based assessment designed to assess spontaneous use and dynamic segmental alignment of the affected UE during functional tasks in children with hemiplegic CP between 3 and 18 years. The SHUEE includes 16 bimanual tasks. Of these 16 tasks, to assess the child's actual function of the affected UE a spontaneous use score is calculated during performance of 9 out of the 16 tasks. This Spontaneous Functional Analysis (SFA) score per task is rated on a scale of 0 to 5, where higher values indicate more spontaneous use of the affect
Baseline
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
52.3
± 3.4
6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
53.3
± 3.4
12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
60.7
± 3.1
Changes in Habitual Arm Activity on the Affected SidePrimary· Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
We will provide children with the Actigraph wrist activity monitors that can be worn like a wristwatch. Children will be asked to wear 2 wrist monitors, one each on both wrists, at 6 timepoints: (a) for one week at the pretest, (b) for one week at mid-point assessment, (c) during first week of training, (d) during last week of training, and (e) for one week at posttest. Children will be provided 2 watches during the pretest visit and they will be requested to wear the watches on both wrists for the next 1 week prior to the start of the training program. Children will be asked to wear the monit
Baseline
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
48.4
± 4.3
at 6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
50.9
± 5.0
at 12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
50.4
± 3.5
Changes in Kinematic Measures of Movement Control on the Affected ArmPrimary· at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
Data will be collected during a unilateral and bilateral reach-grasp task at self-selected speed involving different objects (foam ball, rattle, and square block) placed at half arm's length (near) and at arm's length (far) on the table. Sensors (Inertial Measurement Units (IMUs)) will be placed on both hands, both forearms, both arms, and the C7 spinous process. We will assess range of motion of joints during upper extremity activities.
Overhead shoulder ROM at 6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
113.69
± 6.53
Overhead shoulder ROM at 12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
123.93
± 7.47
Elbow ROM at 6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
112.68
± 7.53
Elbow ROM at 12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
132.59
± 7.08
Wrist Sagittal ROM at 6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
58.72
± 13.80
Wrist Sagittal ROM at 12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
69.78
± 16.59
Treatment SatisfactionPrimary· At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)
Children will complete the valid and reliable 16-item Physical Activity Enjoyment Scale (PAES) to rate their experience with the intervention. The PAES includes a mix of 9 positively phrased (e.g., I enjoy it, It gives me energy, etc.) and 7 negatively phrased (e.g., I feel bored, It's no fun at all, etc.) questions that are rated on a 5-point Likert scale (1: Disagree a lot, 5 - Agree a lot). The negatively coded items were reverse coded and an average total score across all items was calculated. The PAES total score ranges from 1 to 5, with higher scores indicating greater levels of enjoymen
6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
3.7
± 0.2
12 weeks (i.e. following completion of the intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
3.9
± 0.1
Perceived Satisfaction With InterventionPrimary· At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)
Children and caregivers will fill out exit questionnaires to assess training satisfaction, enjoyment, repeatability, and caregiver burden.
number of children reporting high enjoyment
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
12
number of caregivers agreeing RNT is overall beneficial
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
15
Ease of Implementation of TrainingPrimary· At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)
Trainers will fill out posttest exit questionnaires to assess ease of implementation of the training program.
number of children wanting to repeat RNT
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
14
number of caregivers reporting some difficulty in independently delivering RNT
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
9
Changes in Treatment Fidelity Across Training WeeksPrimary· Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
An unbiased coder randomly coded video data (one each of early, mid, and late sessions) from researcher-delivered sessions within the intervention phase using a fidelity checklist to assess adherence to the training protocol. A 159-item fidelity checklist (total possible score: 159) specific to the training program was used for scoring treatment fidelity. Each item was rated on scale of 0 to 1, where 0 meant that the criterion was not satisfied and 1 meant that the fidelity criterion was satisfied. The total scores on the checklist could range from 0 to 159. We calculated a percent fidelity sc
Early (week 1)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
95.1
± 0.7
Mid (week 3)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
96.1
± 0.4
Late (week 6)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
95.6
± 0.7
Changes in Toy Use (in Minutes/Week) Across Training WeeksPrimary· From start to end of 6-week intervention phase on a weekly basis
Sensors mounted on the toy will collect data on amount of use (in minutes/week) of the toy during training weeks. We will assess toy use on a weekly basis across the training period.
Week 1 Duration
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
34.3
± 3.6
Week 2 Duration
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
41.5
± 5.7
Week 3 Duration
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
44.2
± 5.1
Week 4 Duration
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
40.4
± 4.1
Week 5 Duration
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
38.5
± 5.5
Week 6 Duration
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
60.4
± 9.7
# of Training Sessions Completed Assessed Using Training LogsPrimary· From start to end of 6-week intervention phase on a weekly basis
Researchers will also maintain training logs during the intervention phase to document # of training sessions completed out of the total possible sessions (12).
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
98.33
± 1.21
Changes in Parent-rated Scores on Functional Use of the Affected ArmSecondary· Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
The ABILHAND-Kids is a valid and reliable parent-rated questionnaire assessing parent perceptions of their child's level of ease or difficulty in performing 21 manual activities independently over the last 3 months. The questionnaire has been validated as a measure of manual ability for 6-16-year-old children with CP. The 21 manual activities are rated by parents on a 3-point scale of "impossible" (given a score of 0), "difficult" (given a score of 1), or "easy" (given a score of 2). ABILHAND score is expressed in logits, resulting from the conversion of the ordinal raw score into a linear mea
Baseline
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
0.1
± 0.4
6-weeks (i.e., at the end of the control phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
0.5
± 0.3
12-weeks (i.e., at the end of intervention phase)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
1.2
± 0.3
Changes in Amount of Trainer Assistance Needed During NavigationSecondary· Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
Early, mid, \& late training sessions will be coded for % duration of assisted (child needs trainer-provided manual assistance) versus independent navigation.
Early (week 1)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
73.4
± 4.3
Mid (week 3)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
88.7
± 3.3
Late (week 6)
Group
Value
95% CI
Single Joystick Ride-on-car Navigation Training
95.4
± 1.7
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Connecticut
Last refreshed: 17 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05559320.