Effect of a Humanoid Robot With Virtual Reality Games to Train Arm Function in Children With Cerebral Palsy - THRIVE Trial

Georgia State University

Status: Enrolling

Conditions: Cerebral Palsy (CP)

Treatments: Device: Robot; Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06881407

90IFST0009 (Other Grant/Funding Number)

H23116

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 5 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

THRIVE (Combination of Virtual Reality and Humanoid Robot)

Experimental group

Description:

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.

Treatment:

Device: Virtual Reality

Device: Robot

Virtual Reality Alone

Active Comparator group

Description:

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.

Treatment:

Device: Virtual Reality