Clinical trial NCT06881407: Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial
Official title: Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral palsy
Virtual Reality
Humanoid Robot
Home-based Intervention
Arm Function
Lead sponsor: Georgia State University
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2025-03-18
Enrollment: 42
Sex: ALL
Minimum age (years): 5
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reaching kinematics
timeFrame: Baseline, at 9th week, and at 13th week.
measure: Standardized fine motor assessment score
timeFrame: Baseline, at 9th week, and at 13th week.
measure: Daily use of affected hand
timeFrame: Baseline, at 9th week, and at 13th week.
Secondary outcomes:
measure: Muscle strength
timeFrame: Baseline, at 9th week, and at 13th week.
measure: Range of Motion (ROM)
timeFrame: Baseline, at 9th week, and at 13th week.
measure: Spasticity
timeFrame: Baseline, at 9th week, and at 13th week.
Other outcomes:
measure: Qualitative outcome
timeFrame: Baseline, at 9th week, and at 13th week.
Locations:
city: Atlanta
country: United States
facility: Department of Physical Therapy, Georgia State University
state: Georgia
Study officials:
References:
citation: 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.
citation: Howard 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
citation: 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.
citation: Chen 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.