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

NCT05559320 | Completed Results FDA Device

• 2 other identifiers: H22-00591P2CHD101912-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hemiplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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

  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 (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase

• Changes in Child Attention During Training Sessions

  Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase

• Changes in Child Affect Across Training Sessions

  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

  Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)

Study Arms (1)

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.

Device: Ride-on-toy navigation training; Behavioral: Upper extremity functional training

Interventions

Ride-on-toy navigation training DEVICE

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.

Single Joystick Ride-on-car Navigation Training

Upper extremity functional training BEHAVIORAL

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.

Single Joystick Ride-on-car Navigation Training

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Connecticut: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Virginia Tech (National Pediatric Rehabilitation Resource Center i.e. C-PROGRESS): collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator
• American Academy of Cerebral Palsy and Developmental Medicine: collaborator

Study Sites (1)

Physical Therapy Program, Department of Kinesiology, University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (2)

• 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.

  PMID: 36044637 BACKGROUND

• Shahane 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.

  PMID: 37160396 DERIVED

Related Links

• Related Info

Results Point of Contact

• Title: Dr. Sudha Srinivasan
• Organization: University of Connecticut Department of Kinesiology

sudha.srinivasan@uconn.edu

(860)-486-6192

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 29, 2022
• Study Start: November 15, 2022
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)