Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

About 60% of children with cerebral palsy (CP) have impaired arm function. Improving arm function requires hundreds of repetitions per day, which is impossible in a single clinical visit. Thus, therapeutic exercises should be sustained in the home environment; however, the compliance in performing home exercise is low due to poor motivation, boredom, and forgetfulness. A better home program is needed. The objective of this project is to examine the effect of our developed THRIVE system (Therapeutic Humanoid Robot In Virtual Environment: the combination of robot with virtual reality games), which can provide a motivating and tailored upper-extremity intervention program with instant feedback, to improve arm function in children with CP at their home. The investigators believe the newly developed THRIVE system can increase children's engagement and motivation in home exercises as the robot is their playmate to demonstrate and correct their movements. The investigators will also interview parents and children with CP to understand their impression of using technology at home to shape the intervention. The expected outcome is that children with CP receiving THRIVE will improve their arm function more and have better engagement than those who receive VR alone immediately after intervention and at follow-up. The long-term goal is to have the THRIVE system be the optimal home exercise platform as it can provide challenging but motivating exercises to improve children's arm function while assisting parents in supervising their children with CP to complete home exercises.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 21
Healthy Volunteers: f
View:

• Participants are between the ages of 5 and 21 years;

• diagnosed with spastic CP;

• have a manual ability classification system (MACs) level I-III;

• able to sit with trunk supported;

• are able to reach forward for more than half of their arm length;

• are able to comprehend and complete a three-steps commands;

• are able to see a TV screen (with or without corrected vision); and

• their primary caregiver is willing to follow the desired intervention dosing and all evaluation measurements.

Locations
United States
Georgia
Department of Physical Therapy, Georgia State University
RECRUITING
Atlanta
Contact Information
Primary
Yuping Chen, ScD, PT
ypchen@gsu.edu
404-413-1256
Backup
Bruna de Souza da Silva, BS, PT
bdesouzadasilva1@gsu.edu
Time Frame
Start Date: 2025-02-25
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 42
Treatments
Experimental: THRIVE (Combination of Virtual Reality and Humanoid Robot)
Participants will receive the home-based intervention using the combination of virtual reality and a humanoid robot, who serves as a cheerleader and coach, for 8 weeks. During each week, participants will need to exercise 3 sessions per week, for around 60 minutes per session.
Active_comparator: Virtual Reality Alone
Participants will receive the home-based virtual reality intervention for 8 weeks. During each week, participants will need to exercise 3 sessions per week, for around 60 minutes per session.
Related Therapeutic Areas
Sponsors
Leads: Georgia State University
Collaborators: Ohio State University

This content was sourced from clinicaltrials.gov