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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Reaching kinematics [Срок оценки: Baseline, at 9th week, and at 13th week.]
• Standardized fine motor assessment score [Срок оценки: Baseline, at 9th week, and at 13th week.]
• Daily use of affected hand [Срок оценки: Baseline, at 9th week, and at 13th week.]

Вторичные конечные точки (3)

• Muscle strength [Срок оценки: Baseline, at 9th week, and at 13th week.]
• Range of Motion (ROM) [Срок оценки: Baseline, at 9th week, and at 13th week.]
• Spasticity [Срок оценки: Baseline, at 9th week, and at 13th week.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Department of Physical Therapy, Georgia State University — Atlanta

Публикации

• 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. PMID 28816558
• 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
• 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. PMID 24724587
• 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. PMID 29088476

Идентификаторы

NCT: NCT06881407 · H23116 · 90IFST0009

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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