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NCT Number: NCT06881407

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

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

5 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Therapy, Georgia State University

Atlanta, Georgia, 30302, United States

Location status: Recruiting

Location contact

Bruna de Souza da Silva, BS, PT

CONTACT

[email protected]

Yuping Chen, ScD, PT

CONTACT

[email protected]

404-413-1256

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Robot

Device

This robot will serve as a cheerleader and coach to provide encouragement and feedback.

Other names: Humanoid Robot

Virtual reality

Device

Our developed Super Pop VR system will be used to provide virtual reality intervention.

Other names: VR

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruna de Souza da Silva, BS, PT

CONTACT

[email protected]

Yuping Chen, ScD, PT

CONTACT

[email protected]

404-413-1256

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • Ohio State University

Registry information

Acronym: THRIVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 18, 2025
Registry last updated
Mar 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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