Facilitating Neuroplastic Changes of Acute Stroke Survivors

Официальное название

Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia

Обзор

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Подробное описание

Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Вмешательства

• Устройство Motor relearning training
  Ankle motor control relearning training under real-time feedback
• Устройство Passive stretching
  Passive stretching under intelligent robotic control
• Устройство Gamed-based active movement training
  Active movement training through movement games with robotic assistance
• Устройство Passive movement
  Passive movement in the joint middle range of motion
• Устройство Active movement training
  Active movement training without robotic assistance
• Устройство Ankle torque and motion measurement
  Ankle torque and motion measurement with no real-time feedback

Первичные конечные точки

• Fugl-Meyer Lower Extremity (FMLE) [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]]

Вторичные конечные точки (6)

• Active range of motion (AROM) [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Passive Range of Motion (PROM) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly. [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Strength of the ankle flexor-extensor muscle will be measured in Newtons [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Modified Ashworth Scale (MAS) [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Berg Balance Scale [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• 10-meter Walk Test [Срок оценки: At the beginning and end of 3-week training, and 1 month after the treatment ends]

Критерии участия

Критерии включения

• Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
• Hemiplegia or hemiparesis
• 0≤Manual Muscle Testing (MMT)<=2
• Age 30-85
• Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

Критерии исключения

• Medically not stable
• Associated acute medical illness that interferes with ability to training and exercise
• No impairment or very mild ankle impairment of ankle
• Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
• Cognitive impairment or aphasia with inability to follow instructions
• Severe pain in legs
• Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
• Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

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 · 3 центра

• University of Maryland Baltimore — Baltimore
• UMROI — Baltimore
• TIRR Memorial Hermann — Houston

Публикации

• Zhang C, Huang MZ, Kehs GJ, Braun RG, Cole JW, Zhang LQ. Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2252-2259. doi: 10.1109/TNSRE.2021.3121204. Epub 2021 Nov 4. PMID 34665733
• Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30. PMID 22466792
• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. PMID 21571152
• Nudo RJ, Milliken GW. Reorganization of movement representations in primary motor cortex following focal ischemic infarcts in adult squirrel monkeys. J Neurophysiol. 1996 May;75(5):2144-9. doi: 10.1152/jn.1996.75.5.2144. PMID 8734610
• Ren Y, Wu YN, Yang CY, Xu T, Harvey RL, Zhang LQ. Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):589-596. doi: 10.1109/TNSRE.2016.2584003. Epub 2016 Jun 22. PMID 27337720
• Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89. PMID 12509602
• Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305. PMID 16344031
• Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016/j.apmr.2014.04.010. Epub 2014 May 2. PMID 24792141

Идентификаторы

NCT: NCT06404268 · HP-00110205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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