Robotic Exoskeleton Assisted Gait Post Stroke

Официальное название

Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke

Обзор

The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.

Подробное описание

The purpose of this research study is to assess whether using a wearable device, called the robotic exoskeleton (RE), can be helpful in improving recovery of walking in adults who have recently had a stroke. The study will compare the walking abilities of people who went through standard of care treatment after a stroke to those who used the robotic exoskeleton as part of their rehabilitation. This study will also look at the effects walking in the RE has on brain activity. The name of the robotic exoskeleton that is being used in this study is the EksoTM.

Вмешательства

• Устройство EksoGT™, Ekso Bionics, Berkley, CA, USA
  The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking.
• Другое Standard of Care
  Standard gait therapy provided by licensed physical therapists post stroke.
• Другое No Intervention
  Testing Only

Первичные конечные точки

• Functional Independence Measure (FIM) (aim 1) [Срок оценки: Change from Baseline FIM at 10 weeks]
• Within-brain functional connectivity (aim 2) [Срок оценки: Change from Baseline Within-brain functional connectivity at 10 weeks]
• TMS recruitment curve slope (aim 3) [Срок оценки: Change from Baseline TMS recruitment curve slope at 10 weeks]
• electroencephalogram (EEG) (aim 3) [Срок оценки: Change from Baseline EEG at 10 weeks]
• electromyography (EMG) (aim 3) [Срок оценки: Change from Baseline EMG at 10 weeks]
• 10MWT (aims 1-3) [Срок оценки: Change from Baseline 10MWT at 10 weeks]
• 6MWT (aims 1-3) [Срок оценки: Change from Baseline 6MWT at 10 weeks]
• TUG (aims 1-3) [Срок оценки: Change from Baseline TUG at 10 weeks]
• structural connectivity (aim 2) [Срок оценки: Change from Baseline structural connectivity at 10 weeks]

Критерии участия

Критерии включения

• Stroke survivors < 4 weeks from most recent stroke.
• Age: 21- 80 years
• Unilateral hemiparesis
• Medical clearance by the Medical Director
• Be able to physically fit into the exoskeleton device.
• Have joint range of motion within normal functional limits for ambulation.
• Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE.
• Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions.
• Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback.
• No history of injury or pathology to the unaffected limb.
• physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.

Критерии исключения

• Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
• Skin issues that would prevent wearing the device.
• Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
• Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
• Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
• History of severe cardiac disease such as myocardial infarction, congestive heart failure
• Uncontrolled seizure disorder.
• Uncontrolled spasticity or joint contracture that would interfere with walking in the RE and limits normal ROM during ambulation with assistive devices.
• Neuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
• Orthopedic pathologies or history that will interfere with ambulation or limit the ROM of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
• Any metal implants that are NOT MRI-compatible

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Kessler Foundation — West Orange

Идентификаторы

NCT: NCT04309305 · R-1073-19

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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