NCT06881407 Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial
| NCT ID | NCT06881407 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Georgia State University |
| Condition | Cerebral Palsy (CP) |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 42 participants in total. It began in 2025-02-25 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Participants are between the ages of 5 and 21 years; 2. diagnosed with spastic CP; 3. have a manual ability classification system (MACs) level I-III; 4. able to sit with trunk supported; 5. are able to reach forward for more than half of their arm length; 6. are able to comprehend and complete a three-steps commands; 7. are able to see a TV screen (with or without corrected vision); and 8. their primary caregiver is willing to follow the desired intervention dosing and all evaluation measurements. Exclusion Criteria: 1. they have received surgery or botulinum toxin type A injection in the training arm within the preceding 4 months or are scheduled to receive it during the planned intervention period, or 2. if they have a severe attention deficit or uncontrolled epilepsy, which may possibly be triggered by the light or sound of the video games.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06881407 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 21 Years, studying Cerebral Palsy (CP). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06881407 currently recruiting?
Yes, NCT06881407 is actively recruiting participants. Contact the research team at ypchen@gsu.edu for enrollment information.
Where is the NCT06881407 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT06881407 clinical trial?
NCT06881407 is sponsored by Georgia State University. The trial plans to enroll 42 participants.
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