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

University of Connecticut

Status: Completed

Conditions: Hemiplegic Cerebral Palsy

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05559320

H22-0059

1P2CHD101912-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 3 to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Single Joystick Ride-on-car Navigation Training

Experimental group

Description:

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.

Treatment:

Device: Ride-on-toy navigation training

Behavioral: Upper extremity functional training