Thinking of joining a study?

Register your interest

NCT05559320 | Recruiting | Hemiplegic Cerebral Palsy


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

University of Connecticut

Information provided by (Responsible Party):

Sudha Srinivasan

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.

Condition or disease

Hemiplegic Cerebral Palsy

Intervention/treatment

Ride-on-toy navigation training

Upper extremity functional training

Phase

Not Applicable

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 Type : Interventional
Estimated Enrollment : 15 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : November 15, 2022
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : April 30, 2025
Arm Intervention/treatment

Experimental: Single Joystick Ride-on-car Navigation Training

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

Ages Eligible for Study: 3 Years to 8 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

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

Location Details


Please Choose a site



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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Recruiting

United States, Connecticut

Physical Therapy Program, Department of Kinesiology, University of Connecticut

Storrs, Connecticut, United States, 06269

Loading...