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

Trial Summary

What is the purpose of this trial?

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

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

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

Treatment Details

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.

Participant Groups

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+