Exoskeleton for Balance

Официальное название

Improving Mediolateral Walking Balance With an Assistive Exoskeleton

Обзор

Many people who have experienced a stroke have deficits in their walking balance. The long-term goal of this research is to develop an exoskeleton that can effectively improve walking balance, thus improving functional mobility.

Подробное описание

Walking balance is an important component of functional mobility, with post-stroke balance deficits contributing to a fall rate more than double that of age-matched controls. Unfortunately, traditional therapy approaches have not succeeded in addressing balance deficits or reducing fall risk, motivating the use of technology to fill this gap. Although assistive exoskeletons are a promising approach to improve post-stroke mobility, they have generally not been designed to control walking balance and agility. This limitation is a particular concern in the development of devices for people with stroke, as applying forces to "assist" some aspect of walking (including balance) can have unexpected negative effects. The project goal is to investigate the potential of exoskeleton assistance to improve walking balance that will be accepted by people with stroke. To this end, investigators will use a previously developed hip exoskeleton to quantify the effects of assisting gait stabilization.

Вмешательства

• Устройство No Exoskeleton
  The participant will not wear an exoskeleton
• Устройство Exoskeleton (zero impedance)
  The participant will wear an exoskeleton with zero impedance
• Устройство Exoskeleton (low impedance)
  The participant will wear an exoskeleton with low joint impedance
• Устройство Exoskeleton (medium impedance)
  The participant will wear an exoskeleton with medium joint impedance
• Устройство Exoskeleton (high impedance)
  The participant will wear an exoskeleton with high impedance

Первичные конечные точки

• Partial correlation (rSW) between mediolateral pelvis displacement and step width during unperturbed walking [Срок оценки: Visit 2, anticipated average 1 week]
• Partial correlation (rSW) between mediolateral pelvis displacement and step width during speed perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Partial correlation (rSW) between mediolateral pelvis displacement and step width during vision perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Partial correlation (rSW) between mediolateral pelvis displacement and step width during mediolateral pull perturbations [Срок оценки: Visit 4, anticipated average 1 year]

Вторичные конечные точки (12)

• Partial correlation between mediolateral pelvis displacement and mediolateral foot placement (unperturbed walking) [Срок оценки: Visit 2, anticipated average 1 week]
• Average gluteus medius activity during stance phase (surface EMG) in unperturbed walking [Срок оценки: Visit 2, anticipated average 1 week]
• Average gluteus medius activity during swing phase (surface EMG) in unperturbed walking [Срок оценки: Visit 2, anticipated average 1 week]
• Rating of Perceived Stability (RPS) during unperturbed walking [Срок оценки: Visit 2, anticipated average 1 week]
• Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during speed perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Average gluteus medius activity during stance phase (surface EMG) with speed perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Average gluteus medius activity during swing phase (surface EMG) with speed perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Rating of Perceived Stability (RPS) with speed perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Partial correlation between mediolateral pelvis displacement and mediolateral foot placement during vision perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Average gluteus medius activity during stance phase (surface EMG) with vision perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Average gluteus medius activity during swing phase (surface EMG) with vision perturbations [Срок оценки: Visit 4, anticipated average 1 year]
• Rating of Perceived Stability (RPS) with vision perturbations [Срок оценки: Visit 4, anticipated average 1 year]

Критерии участия

Критерии включения

• Evidence of a stroke at least 6 months prior to participation
• Evidence of dysfunction of the paretic lower limb (Fugl-Meyer lower extremity motor score < 34)
• At least 21 years of age
• Self-reported experience of a fall in the previous year, and/or a fear of falling
• Gait speed of at least 0.2 m/s
• Ability to walk on a treadmill without a cane or walker
• Ability to follow three step commands and communicate with experimenters to answer questions (e.g., regarding their balance confidence)
• Provision of informed consent

Критерии исключения

• Resting blood pressure higher than 220/110 mm Hg
• History of unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
• Preexisting neurological orders or dementia
• Legal blindness or severe visual impairment
• Presence of neglect
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Orthopedic injuries or conditions (e.g., joint replacements) in the lower extremities with the potential to alter the gait pattern

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07356011 · Pro00135871 · REGE22000170

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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