Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial
THRIVE
2 other identifiers
interventional
42
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2025
CompletedFirst Submitted
Initial submission to the registry
February 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 18, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 18, 2025
March 1, 2025
1.5 years
February 27, 2025
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Baseline, at 9th week, and at 13th week.
Secondary Outcomes (3)
Muscle strength
Baseline, at 9th week, and at 13th week.
Range of Motion (ROM)
Baseline, at 9th week, and at 13th week.
Spasticity
Baseline, at 9th week, and at 13th week.
Other Outcomes (1)
Qualitative outcome
Baseline, at 9th week, and at 13th week.
Study Arms (2)
THRIVE (Combination of Virtual Reality and Humanoid Robot)
EXPERIMENTALParticipants 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.
Virtual Reality Alone
ACTIVE COMPARATORParticipants 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
This robot will serve as a cheerleader and coach to provide encouragement and feedback.
Our developed Super Pop VR system will be used to provide virtual reality intervention.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgia State Universitylead
- Ohio State Universitycollaborator
Study Sites (1)
Department of Physical Therapy, Georgia State University
Atlanta, Georgia, 30302, United States
Related Publications (4)
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.
PMID: 28816558BACKGROUNDHoward 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
BACKGROUNDChen 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.
PMID: 24724587BACKGROUNDChen 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.
PMID: 29088476BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 18, 2025
Study Start
February 25, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
March 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- 9/1/2027 - after the data collection is completed and data have been analyzed and disseminated. Data will be available until 12/31/2035.
- Access Criteria
- Reserachers who also sign up to participate in datasharing in Databrary.
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.