Recruiting

THRIVE System

Sponsor:

Georgia State University

Code:

NCT06881407

Conditions

Cerebral Palsy (CP)

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

Interventions

Robot

Virtual Reality

Study Details

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.

Conditions

Cerebral Palsy (CP)

Study ID

NCT06881407

Start date

Feb 25, 2025

Status verified date

Aug, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Robot

This robot will serve as a cheerleader and coach to provide encouragement and feedback.

Virtual Reality

Our developed Super Pop VR system will be used to provide virtual reality intervention.

Primary outcome measure

  • Reaching kinematics [ Time Frame: Baseline, at 9th week, and at 13th week. ]
  • Standardized fine motor assessment score [ Time Frame: Baseline, at 9th week, and at 13th week. ]
  • Daily use of affected hand [ Time Frame: Baseline, at 9th week, and at 13th week. ]

Central Contacts and Locations

Central contacts

Yuping Chen, ScD, PT

404-413-1256ypchen@gsu.edu

Bruna de Souza da Silva, BS, PT

bdesouzadasilva1@gsu.edu

Locations

Department of Physical Therapy, Georgia State University

Recruiting

Atlanta, Georgia, United States, 30302

Contacts

Yuping Chen, ScD, PT

404-413-1256ypchen@gsu.edu

Bruna de Souza da Silva, BS, PT

bdesouzadasilva1@gsu.edu

More Information

Sponsor

Georgia State University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Cerebral palsy
  • Virtual Reality
  • Humanoid Robot
  • Home-based Intervention
  • Arm Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgia State University on 2026-08-20.