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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Georgia State University
Study ID
NCT06881407
Status
Recruiting
Apply to this trial

Conditions

  • Cerebral Palsy (CP)

Eligibility Criteria

Sex
ALL
Age
5 Years - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Robot — DEVICE
    This robot will serve as a cheerleader and coach to provide encouragement and feedback.
  • Virtual Reality — DEVICE
    Our developed Super Pop VR system will be used to provide virtual reality intervention.

Study Details

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.

Key Dates

Start date
Feb 25, 2025
Status verified
Mar 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Reaching kinematics [ Time Frame: Baseline, at 9th week, and at 13th week. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Physical Therapy, Georgia State UniversityAtlantaGeorgia30302
Yuping Chen, ScD, PT
[email protected]
404-413-1256
Bruna de Souza da Silva, BS, PT
[email protected]

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By research site
Department of Physical Therapy, Georgia State University· Atlanta, GA

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