Hemiplegic Cerebral PalsyNCT05559320
Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy
A study testing Ride-on-toy navigation training and Upper extremity functional training in people with Hemiplegic Cerebral Palsy, run by University of Connecticut at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 8 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Ride-on-toy navigation training and Upper extremity functional training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2022to 11 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Therapy Program, Department of Kinesiology, University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Effects of a Novel, Home-based Training Program Using a Joystick-operated, Modified, Powered Ride-on-car on Bilateral Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
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.
Read the detailed description
Prior to the start of the study, researchers will conduct a phone screening with the family to confirm their child's eligibility to participate in the study. Once eligibility is confirmed, during the pretest session, standardized assessments will be conducted to evaluate the child's ability to use their affected arm for different functional activities. During this testing visit, researchers will also use small sensors on the child's arms and observe their movements as they complete a reaching task. In addition, caregivers will be asked to complete questionnaires to obtain information on their child's overall health, development, and their ability to use their affected arm for various activities of daily living.
Assessments and questionnaires will be repeated again at the mid-point of the study (that corresponds with completion of the 6-week control phase), and at posttest (that corresponds with completion of the 6-week home-based intervention phase). Researchers will video record all testing and training sessions so that children's performance can be scored later. Children will also be asked to wear wrist monitors on both hands to assess their habitual activity levels on dominant and non-dominant arms for 1 week at the pretest, at the mid-point assessment, during the first and last weeks of the training, and at posttest.
This study consists of 2 phases: the control phase and the intervention phase. During the first 6-week control phase, the researchers will contact families on a weekly basis to obtain information regarding different therapies that their child receives both in and out of school. In the next 6-week intervention phase, researchers will visit the child's home twice a week to provide a training program involving joystick-operated ride-on-toys that will encourage the child to use their affected arm to control and navigate the ride-on-car through their physical environment. During the intervention phase the ride-on-car will be left at the child's home so that children can practice driving the car under caregiver supervision for additional days during the week. All testing sessions will be conducted before and after the control and intervention phases of the study.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Ride-on-toy navigation training, Upper extremity functional training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ride-on-toy navigation trainingDevice
The training program will involve a set of activities where children will be encouraged to drive a joystick-operated ride-on-toy to navigate through their physical environment. The training will involve will involve progressively challenging multi-directional navigational games such as shape mazes, treasure hunts, relay races, and obstacle courses that will require children to use their affected arm skillfully to navigate through the courses.
Upper extremity functional trainingBehavioural
In addition to the navigation practice, along the multi-directional courses, children will complete tasks at multiple stations that will involve both gross and fine motor activities. The goal of the training will be to use their arm for functional goal-directed tasks and games that will involve elements of reaching, grasping, in-hand manipulation, and release. We will use props such as balls, bean bags, cups, cones, and small toys to practice skills such as catching, throwing, picking up, pushing, pulling, opening, closing, etc.
| Study group | Role | What they receive |
|---|---|---|
| Single Joystick Ride-on-car Navigation Training | Experimental | Participants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls. Receives: Device: Ride-on-toy navigation training; Behavioral: Upper extremity functional training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Affected Arm Movement Control
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 tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.
Measured: 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
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 affected UE. We summed the SFA scores across all 9 tasks, divided this sum by the total possible score, and then multiplied this value by 100 to express SFA as a percentage of normal or optimal score.
Measured: 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
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 monitor continuously when awake and while sleeping for a minimum of 4 days - 1 weekend day and 3 weekdays.
Measured: 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
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.
Measured: 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
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 enjoyment with training activities.
Measured: 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
Children and caregivers will fill out exit questionnaires to assess training satisfaction, enjoyment, repeatability, and caregiver burden.
Measured: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)
Ease of Implementation of Training
Trainers will fill out posttest exit questionnaires to assess ease of implementation of the training program.
Measured: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)
Changes in Treatment Fidelity Across Training Weeks
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 score by dividing the total score received by the total possible score (i.e., 159) and then multiplied this value by 100.
Measured: Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
Changes in Toy Use (in Minutes/Week) Across Training Weeks
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.
Measured: From start to end of 6-week intervention phase on a weekly basis
# of Training Sessions Completed Assessed Using Training Logs
Researchers will also maintain training logs during the intervention phase to document # of training sessions completed out of the total possible sessions (12).
Measured: From start to end of 6-week intervention phase on a weekly basis
Secondary outcomes (7)
Changes in Parent-rated Scores on Functional Use of the Affected Arm
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 measure of ability located on a unidimensional scale. The logit is a linear unit that expresses the odds of success of the patient on any given item. This unit is constant throughout the measurement scale. The manual ability scale is, by convention, centered on the average item difficulty (0 logit), the scale ranging from -6.75 to 6.68, with higher scores indicating better manual abilities.
Measured: 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 Amount of Trainer Assistance Needed During Navigation
Early, mid, \& late training sessions will be coded for % duration of assisted (child needs trainer-provided manual assistance) versus independent navigation.
Measured: Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
Changes in Child Attention During Training Sessions
Training sessions (one early, mid, and late session each) will be video-coded for attention (i.e., % duration of attention to task-relevant targets).
Measured: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase
Changes in Child Affect Across Training Sessions
Training sessions (one early, mid, and late session each) will be video-coded for child affect (i.e., smile rates, % duration of positive/interested and negative affect)
Measured: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase
Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions
The path navigation test will be coded for the average duration of child-initiated, movement bouts normalized by driving time (a bout comprises 1 acceleration and 1 deceleration phase).
Measured: 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 Rates of Obstacle Contacts Across Testing Sessions
The path navigation test will be coded for the number of times the child bumps/crashes against obstacles during the navigation. We will report on the number of such bumps/crashes per minute of navigation time. Higher values of this variable indicate worse performance (poor navigational control).
Measured: 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 Rates of Path Deviations Across Testing Sessions
The path navigation test will involve children navigating through paths that are clearly demarcated using tape/chalk. We counted the number of times per minute that children went outside the demarcated path during the navigation test. Higher values of this variable indicate worse performance (poor navigational control).
Measured: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start15 Nov 2022
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Virginia Tech (National Pediatric Rehabilitation Resource Center i.e. C-PROGRESS), National Institute of Neurological Disorders and Stroke (NINDS), National Institute for Biomedical Imaging and Bioengineering (NIBIB), American Academy of Cerebral Palsy and Developmental Medicine
- Responsible party
- Principal investigator, Sudha Srinivasan, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559320
- Sponsor's protocol ID
- H22-0059
- Other IDs
- 1P2CHD101912-01
- Status last verified
- Jun 2025
- First submitted
- 16 Sep 2022
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Amonkar N, Kumavor P, Morgan K, Bubela D, Srinivasan S. Feasibility of Using Joystick-Operated Ride-on-Toys to Promote Upper Extremity Function in Children With Cerebral Palsy: A Pilot Study. Pediatr Phys Ther. 2022 Oct 1;34(4):508-517. doi: 10.1097/PEP.0000000000000944. Epub 2022 Aug 30.
PubMed 36044637Shahane V, Kumavor P, Morgan K, Friel KM, Srinivasan SM. A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP). BMJ Open. 2023 May 9;13(5):e071742. doi: 10.1136/bmjopen-2023-071742.
PubMed 37160396
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Novel, Home-based Training Program Using a Joystick-operated, Modified, Powered Ride-on-car on Bilateral Upper Extremity Function in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05559320
- Acronym / sponsor ID
- H22-0059
- Conditions
- Hemiplegic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Virginia Tech (National Pediatric Rehabilitation Resource Center i.e. C-PROGRESS), National Institute of Neurological Disorders and Stroke (NINDS), National Institute for Biomedical Imaging and Bioengineering (NIBIB), American Academy of Cerebral Palsy and Developmental Medicine
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 29 Sep 2022 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prior to the start of the study, researchers will conduct a phone screening with the family to confirm their child's eligibility to participate in the study. Once eligibility is confirmed, during the pretest session, standardized assessments will be conducted to evaluate the child's ability to use their affected arm for different functional activities. During this testing visit, researchers will also use small sensors on the child's arms and observe their movements as they complete a reaching task. In addition, caregivers will be asked to complete questionnaires to obtain information on their child's overall health, development, and their ability to use their affected arm for various activities of daily living.
Assessments and questionnaires will be repeated again at the mid-point of the study (that corresponds with completion of the 6-week control phase), and at posttest (that corresponds with completion of the 6-week home-based intervention phase). Researchers will video record all testing and training sessions so that children's performance can be scored later. Children will also be asked to wear wrist monitors on both hands to assess their habitual activity levels on dominant and non-dominant arms for 1 week at the pretest, at the mid-point assessment, during the first and last weeks of the training, and at posttest.
This study consists of 2 phases: the control phase and the intervention phase. During the first 6-week control phase, the researchers will contact families on a weekly basis to obtain information regarding different therapies that their child receives both in and out of school. In the next 6-week intervention phase, researchers will visit the child's home twice a week to provide a training program involving joystick-operated ride-on-toys that will encourage the child to use their affected arm to control and navigate the ride-on-car through their physical environment. During the intervention phase the ride-on-car will be left at the child's home so that children can practice driving the car under caregiver supervision for additional days during the week. All testing sessions will be conducted before and after the control and intervention phases of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Joystick Ride-on-car Navigation Training | Experimental | Device: Ride-on-toy navigation training, Behavioral: Upper extremity functional trainingParticipants will first participate in a 6-week control phase followed by a 6-week intervention phase. During the intervention phase, they will receive the ride-on-toy navigation training program. The training will be provided by the researchers twice a week, 30-45 minutes/session for 6 weeks. Caregivers will be asked to provide 2 additional sessions/week during the intervention phase. In this study design, the participants will serve as their own controls. |
Who may qualify
- Ages
- 3 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ride-on-toy navigation trainingThe training program will involve a set of activities where children will be encouraged to drive a joystick-operated ride-on-toy to navigate through their physical environment. The training will involve will involve progressively challenging multi-directional navigational games such as shape mazes, treasure hunts, relay races, and obstacle courses that will require children to use their affected arm skillfully to navigate through the courses. | Device | Single Joystick Ride-on-car Navigation Training |
| Upper extremity functional trainingIn addition to the navigation practice, along the multi-directional courses, children will complete tasks at multiple stations that will involve both gross and fine motor activities. The goal of the training will be to use their arm for functional goal-directed tasks and games that will involve elements of reaching, grasping, in-hand manipulation, and release. We will use props such as balls, bean bags, cups, cones, and small toys to practice skills such as catching, throwing, picking up, pushing, pulling, opening, closing, etc. | Behavioural | Single Joystick Ride-on-car Navigation Training |
Primary outcome
Change in Affected Arm Movement Control
Time frame: 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 tested. The total scores on the QUEST range from 0 to 100. Higher scores represent better quality of movement.
Changes in Use of Affected Arm in Functional Activities
Time frame: 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 affected UE. We summed the SFA scores across all 9 tasks, divided this sum by the total possible score, and then multiplied this value by 100 to express SFA as a percentage of normal or optimal score.
Changes in Habitual Arm Activity on the Affected Side
Time frame: 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 monitor continuously when awake and while sleeping for a minimum of 4 days - 1 weekend day and 3 weekdays.
Changes in Kinematic Measures of Movement Control on the Affected Arm
Time frame: 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.
Treatment Satisfaction
Time frame: 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 enjoyment with training activities.
Perceived Satisfaction With Intervention
Time frame: 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.
Ease of Implementation of Training
Time frame: 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.
Changes in Treatment Fidelity Across Training Weeks
Time frame: 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 score by dividing the total score received by the total possible score (i.e., 159) and then multiplied this value by 100.
Changes in Toy Use (in Minutes/Week) Across Training Weeks
Time frame: 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.
# of Training Sessions Completed Assessed Using Training Logs
Time frame: 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).
7 secondary outcomes
Changes in Parent-rated Scores on Functional Use of the Affected Arm
Time frame: 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 Amount of Trainer Assistance Needed During Navigation
Time frame: Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
Changes in Child Attention During Training Sessions
Time frame: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase
Changes in Child Affect Across Training Sessions
Time frame: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase
Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions
Time frame: 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 Rates of Obstacle Contacts Across Testing Sessions
Time frame: 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 Rates of Path Deviations Across Testing Sessions
Time frame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 36044637Amonkar N, Kumavor P, Morgan K, Bubela D, Srinivasan S. Feasibility of Using Joystick-Operated Ride-on-Toys to Promote Upper Extremity Function in Children With Cerebral Palsy: A Pilot Study. Pediatr Phys Ther. 2022 Oct 1;34(4):508-517. doi: 10.1097/PEP.0000000000000944. Epub 2022 Aug 30.
- Derived from this study: PubMed 37160396Shahane V, Kumavor P, Morgan K, Friel KM, Srinivasan SM. A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP). BMJ Open. 2023 May 9;13(5):e071742. doi: 10.1136/bmjopen-2023-071742.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ride-on-toy navigation training and Upper extremity functional training in people with Hemiplegic Cerebral Palsy, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Affected Arm Movement Control (time frame: 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 study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05559320, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.