Cerebral Palsy (CP)THRIVENCT06881407
Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial
A study testing Robot and Virtual Reality in people with Cerebral Palsy (CP), run by Georgia State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 21 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Robot and Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2025to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
- if they have a severe attention deficit or uncontrolled epilepsy, which may possibly be triggered by the light or sound of the video games.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bruna de Souza da Silva, BS, PT contact
United States1 site, 1 recruiting
- Recruiting
Department of Physical Therapy, Georgia State University
Atlanta, Georgia, 30302
Yuping Chen, ScD, PT, 404-413-1256, ypchen@gsu.edu
Bruna de Souza da Silva, BS, PT, bdesouzadasilva1@gsu.edu
About this study
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)
- Being tested
- Robot, Virtual Reality
- Keywords
- Cerebral palsy, Virtual Reality, Humanoid Robot, Home-based Intervention, Arm Function
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RobotDevice
Also called Humanoid Robot
This robot will serve as a cheerleader and coach to provide encouragement and feedback.
Virtual RealityDevice
Also called VR
Our developed Super Pop VR system will be used to provide virtual reality intervention.
| Study group | Role | What they receive |
|---|---|---|
| THRIVE (Combination of Virtual Reality and Humanoid Robot) | Experimental | 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. Receives: Device: Robot; Device: Virtual Reality |
| Virtual Reality Alone | Active comparator | 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. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching kinematics
Reaching kinematics will be assessed while the child is interacting with Super Pop VR, wherein virtual bubbles are projected onto the standard projecting screen in randomly dispersed locations using the Kinect system. Three testing bubbles will be situated in the location where children need to reach about arm length overhead at 180°, 135°, and 90° of shoulder abduction, with instructions for children to reach in two conditions: (1) as fast as possible and (2) as accurate as possible. Children's reaching kinematics will also be assessed while playing the real-life functional activity using the Kinect camera. All children will be seated in an adjustable chair with a testing table in front of them at waist height with trunk support. Data will be collected for a minimum of six reaches for each direction of virtual and real-life tasks.
Measured: Baseline, at 9th week, and at 13th week.
Standardized fine motor assessment score
The fine motor domain of the Peabody Developmental Motor Scales, 2nd edition (PDMS-2), including grasping and visual-motor integration will be used. The higher score the better.
Measured: Baseline, at 9th week, and at 13th week.
Daily use of affected hand
Daily use of affected hand will be evaluated using the Revised Pediatric Motor Activity Log (R-PMAL), which is filled out by primary caregivers about how often and how well their child uses the affected arm in daily activities.
Measured: Baseline, at 9th week, and at 13th week.
Secondary outcomes (3)
Muscle strength
Muscle strength of shoulder flexion, extension, abductor, adduction, external rotation, internal rotation, elbow flexion and extension, and wrist flexion and extension will be measured using a hand-held dynamometer prior to and after intervention as well as at follow-up.
Measured: Baseline, at 9th week, and at 13th week.
Range of Motion (ROM)
ROM of shoulder flexion, extension, abduction, adduction, external rotation, internal rotation, elbow flexion and extension, and wrist flexion and extension will be measured using a standardized goniometer.
Measured: Baseline, at 9th week, and at 13th week.
Spasticity
Spasticity of shoulder flexion, extension, abduction, adduction, external rotation, internal rotation, elbow flexion and extension, and wrist flexion and extension will also be measured using the Modified Ashworth Scale. It contains a scale of 0 to 4 with 0 as no spasticity to 4 as rigid in flexion or extension.
Measured: Baseline, at 9th week, and at 13th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2025
- Study start25 Feb 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Yuping Chen, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06881407
- Sponsor's protocol ID
- H23116
- Other IDs
- 90IFST0009
- Acronym
- THRIVE
- Status last verified
- Aug 2026
- First submitted
- 27 Feb 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Real user therapy assessment and outcome data and intervention log will be possibility shared to a NIH-funded open video-based data-sharing system for developmental science (i.e., Databrary). Databrary is one of the first large-scale repository for sharing video data and related information so the researchers can share and view on another's databases to promote greater transparency and peer oversight into data collection methods and measurement. All the videos collected through Kinect camera during interventions and evaluations will be de-identified first before sharing to Databrary. A new written permission will be obtained from the parents of children with CP before initiating the data sharing process. PI, Co-PI, and research team members will contact the parents to explain the purpose of data sharing. If parents show their initial agreement, a de-identified video will send it to the parents for review before uploading and sharing to Databrary.
Publications
Chen Y, Garcia-Vergara S, Howard AM. Effect of feedback from a socially interactive humanoid robot on reaching kinematics in children with and without cerebral palsy: A pilot study. Dev Neurorehabil. 2018 Nov;21(8):490-496. doi: 10.1080/17518423.2017.1360962. Epub 2017 Aug 17.
PubMed 28816558Howard A, Chen Y, Park CH. From Autism Spectrum Disorder to Cerebral Palsy: State-of-the-Art in Pediatric Therapy Robots. In Encyclopedia of Medical Robotics, J. P. Desai (Ed.), World Scientific Publishing Company, 2018, pp241-261
Chen YP, Howard AM. Effects of robotic therapy on upper-extremity function in children with cerebral palsy: A systematic review. Dev Neurorehabil. 2016;19(1):64-71. doi: 10.3109/17518423.2014.899648. Epub 2014 Apr 11.
PubMed 24724587Chen Y, Fanchiang HD, Howard A. Effectiveness of Virtual Reality in Children With Cerebral Palsy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Phys Ther. 2018 Jan 1;98(1):63-77. doi: 10.1093/ptj/pzx107.
PubMed 29088476