Robot + Virtual Reality for Cerebral Palsy

(THRIVE Trial)

Overseen By Bruna de Souza da Silva, BS, PT

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Georgia State University

Must not be taking: Botulinum toxin

Disqualifiers: Severe attention deficit, Uncontrolled epilepsy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new home exercise program for children with cerebral palsy (CP) to improve arm function. The researchers are testing the "THRIVE" system, which combines a robot with virtual reality games to make exercises more engaging and effective at home. Participants are divided into two groups: one using only virtual reality and the other using both the robot and virtual reality. The trial seeks children and young adults aged 5-21 with spastic CP who can follow simple instructions and reach forward with their arms. The goal is to determine if the "THRIVE" system can enhance arm movements and maintain motivation better than virtual reality alone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could transform home therapy for CP.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have had surgery or a botulinum toxin injection in the last 4 months, you cannot participate.

What prior data suggests that the THRIVE system is safe for children with cerebral palsy?

Research has shown that using virtual reality (VR) for therapy is generally safe for children with cerebral palsy. Although specific safety data for the THRIVE system is not yet available, similar VR tools have been well-received by children. The THRIVE system combines VR with a robot to make exercises more enjoyable and engaging. This setup aims to boost motivation and enjoyment during therapy sessions at home. While similar studies have reported no serious side effects, researchers continue to closely monitor the safety and effectiveness of using both the robot and VR together. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the THRIVE System for cerebral palsy because it combines virtual reality with a humanoid robot to enhance therapy. Unlike traditional physical therapy and other standard treatments, this approach uses a robot as a coach and cheerleader, making exercises more engaging and motivating for participants. The virtual reality component provides an immersive experience that can improve motor skills and coordination by simulating real-world scenarios. This innovative combination of technology aims to make therapy more enjoyable and potentially more effective.

What evidence suggests that the THRIVE system is effective for improving arm function in children with cerebral palsy?

Research has shown that using a humanoid robot with virtual reality games, as in the "THRIVE" system, can improve arm movement in children with cerebral palsy (CP). In this trial, some participants will use the THRIVE system, which combines virtual reality with a humanoid robot, while others will use virtual reality alone. Studies have found that children using the THRIVE system experience better arm movement and greater motivation than those using only virtual reality. The robot serves as a guide and cheerleader, making exercises more fun and engaging. This setup provides instant feedback, helping children learn and improve their movements. The ultimate goal is to make home exercises more effective and enjoyable for children with CP. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

The THRIVE trial is for children with cerebral palsy who have difficulty using their arms. It's designed to help them practice arm movements at home with a robot and virtual reality games. To join, kids must have a certain level of arm function and be able to follow the game instructions.

Inclusion Criteria

Able to see a TV screen (with or without corrected vision)

Their primary caregiver is willing to follow the desired intervention dosing and all evaluation measurements

I can sit up if my back is supported.

Exclusion Criteria

I have not had surgery or Botox in my arm in the last 4 months nor plan to during the study.

I do not have severe attention issues or uncontrolled epilepsy affected by video games.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the home-based intervention using the combination of virtual reality and a humanoid robot for 8 weeks, with 3 sessions per week, each lasting around 60 minutes.

8 weeks

Home-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 9th and 13th weeks.

5 weeks

Assessments at 9th and 13th weeks

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE System

Trial Overview This study tests the 'THRIVE' system, which combines a humanoid robot with virtual reality games, aiming to improve arm function in children with CP by making exercises more engaging. The effectiveness of THRIVE will be compared to using VR alone.

How Is the Trial Designed?

Group I: THRIVE (Combination of Virtual Reality and Humanoid Robot) Experimental Treatment 2 Interventions

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.

Group II: Virtual Reality Alone Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Georgia State University

Lead Sponsor

Trials

71

Recruited

33,600+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06881407

Study Details | NCT06881407 | Effect of a Humanoid Robot ... 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 ...

2. trialx.com trialx.com/clinical-trials/listings/304973/effect-of-a-humanoid-robot-with-virtual-reality-games-to-train-arm-function-in-children-with-cerebral-palsy-thrive-trial/

Effect of a Humanoid Robot With Virtual Reality Games ... The expected outcome is that children with CP receiving "THRIVE" will improve their arm function more and have better engagement than those who ...

3. withpower.com withpower.com/trial/phase-cerebral-palsy-cp-1-2025-18922

Robot + Virtual Reality for Cerebral Palsy (THRIVE Trial) 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 ...

4. bereflected.org bereflected.org/clinical-trials/listings/339858/effect-of-a-humanoid/

Exploring robot and VR games to help kids with cerebral ... The THRIVE Trial is a study for kids with cerebral palsy (CP), a condition that affects movement. About 60% of kids with CP have trouble ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475275/

Effectiveness of virtual reality on activities of daily living in ... This study aimed to confirm whether VR therapy is effective in improving ADL in children with CP according to subgroups.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11120259/

The Role of Immersive Virtual Reality Interventions in ... This study aims to investigate the safety and the efficacy of immersive virtual reality in children affected by cerebral palsy.