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| ID | Type | Description | Link |
|---|---|---|---|
| 90IFST0009 | Other Grant/Funding Number | National Institute on Disability, Independent Living, and Rehabilitation Research |
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| Name | Class |
|---|---|
| Ohio State University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THRIVE (Combination of Virtual Reality and Humanoid Robot) | Experimental | 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. |
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| Virtual Reality Alone | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot | Device | This robot will serve as a cheerleader and coach to provide encouragement and feedback. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reaching kinematics | 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 | 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 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative outcome | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuping Chen, ScD, PT | Contact | 404-413-1256 | ypchen@gsu.edu | |
| Bruna de Souza da Silva, BS, PT | Contact | bdesouzadasilva1@gsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Therapy, Georgia State University | Recruiting | Atlanta | Georgia | 30302 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28816558 | Background | 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. | |
| Background | 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 | ||
| 24724587 |
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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.
9/1/2027 - after the data collection is completed and data have been analyzed and disseminated. Data will be available until 12/31/2035.
Reserachers who also sign up to participate in datasharing in Databrary.
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065287 | Robotic Surgical Procedures |
| ID | Term |
|---|---|
| D025321 | Surgery, Computer-Assisted |
| D013514 | Surgical Procedures, Operative |
| D012371 | Robotics |
| D001331 | Automation |
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| Virtual Reality | Device | Our developed Super Pop VR system will be used to provide virtual reality intervention. |
|
|
| Range of Motion (ROM) |
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 | 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. |
| Background |
| 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. |
| 29088476 | Background | 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. |
| D013672 |
| Technology |
| D013676 | Technology, Industry, and Agriculture |