Clinical trial NCT05559320: Use of Joystick-operated Ride-on-toys to Improve Affected Arm Use and Function in Children With Hemiplegic Cerebral Palsy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Virginia Tech (National Pediatric Rehabilitation Resource Center i.e. C-PROGRESS)
name: National Institute of Neurological Disorders and Stroke (NINDS)
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: American Academy of Cerebral Palsy and Developmental Medicine
First posted: 2022-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in Affected Arm Movement Control
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Changes in Use of Affected Arm in Functional Activities
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Changes in Habitual Arm Activity on the Affected Side
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Changes in Kinematic Measures of Movement Control on the Affected Arm
timeFrame: at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Treatment Satisfaction
timeFrame: At 6-weeks (i.e., at the end of the control phase), at 12 weeks (i.e. following completion of the intervention phase)
measure: Perceived Satisfaction With Intervention
timeFrame: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)
measure: Ease of Implementation of Training
timeFrame: At 12 weeks (i.e. following completion of the intervention and control phases each lasting for 6 weeks)
measure: Changes in Treatment Fidelity Across Training Weeks
timeFrame: Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
measure: Changes in Toy Use (in Minutes/Week) Across Training Weeks
timeFrame: From start to end of 6-week intervention phase on a weekly basis
measure: # of Training Sessions Completed Assessed Using Training Logs
timeFrame: From start to end of 6-week intervention phase on a weekly basis
Secondary outcomes:
measure: Changes in Parent-rated Scores on Functional Use of the Affected Arm
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Changes in Amount of Trainer Assistance Needed During Navigation
timeFrame: Early (week 1), mid (week 3), and late (week 6) training sessions within the 6-week intervention phase
measure: Changes in Child Attention During Training Sessions
timeFrame: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase
measure: Changes in Child Affect Across Training Sessions
timeFrame: Early (week 1), mid (week 3), and late (week 6) sessions during the 6-week intervention phase
measure: Changes in the Duration of Movement Bouts During Navigation Across Testing Sessions
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Changes in Rates of Obstacle Contacts Across Testing Sessions
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
measure: Changes in Rates of Path Deviations Across Testing Sessions
timeFrame: Baseline, at 6-weeks (i.e., at the end of the control phase), at 12-weeks (i.e., at the end of intervention phase)
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Physical Therapy Program, Department of Kinesiology, University of Connecticut
state: Connecticut
Study officials:
References:
citation: 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.