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

March 11, 2025 updated by: Yuping Chen, Georgia State University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yuping Chen, ScD, PT
  • Phone Number: 404-413-1256
  • Email: ypchen@gsu.edu

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Recruiting
        • Department of Physical Therapy, Georgia State University
        • Contact:
          • Yuping Chen, ScD, PT
          • Phone Number: 404-413-1256
          • Email: ypchen@gsu.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: Robot
This robot will serve as a cheerleader and coach to provide encouragement and feedback.
Other Names:
  • Humanoid Robot
Device: Virtual Reality
Our developed Super Pop VR system will be used to provide virtual reality intervention.
Other Names:
  • VR
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.
Device: Virtual Reality
Our developed Super Pop VR system will be used to provide virtual reality intervention.
Other Names:
  • VR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaching kinematics
Time Frame: Baseline, at 9th week, and at 13th week.
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
Time Frame: Baseline, at 9th week, and at 13th week.
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
Time Frame: Baseline, at 9th week, and at 13th week.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle strength
Time Frame: Baseline, at 9th week, and at 13th week.
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.
Baseline, at 9th week, and at 13th week.
Range of Motion (ROM)
Time Frame: Baseline, at 9th week, and at 13th week.
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.
Baseline, at 9th week, and at 13th week.
Spasticity
Time Frame: Baseline, at 9th week, and at 13th week.
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.
Baseline, at 9th week, and at 13th week.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative outcome
Time Frame: Baseline, at 9th week, and at 13th week.
Researcher will conduct semi-structured interview to explore the parents' and children's expectations (pre-intervention) and perceptions (post-intervention and follow-up) as well as knowledge (all 3 timepoints) about the technology we used to conduct the intervention and about the barriers and facilitators to have parents implement the technology.
Baseline, at 9th week, and at 13th week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgia State University

Collaborators

Ohio State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23116
  • 90IFST0009 (Other Grant/Funding Number: National Institute on Disability, Independent Living, and Rehabilitation Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

Reserachers who also sign up to participate in datasharing in Databrary.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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