Multisensory Augmentation for Post-stroke Standing Balance

Официальное название

Multisensory Augmentation to Improve the Standing Balance of People With Chronic Stroke

Обзор

Many individuals who experience a stroke have problems with their balance. In part, these balance problems may be due to sensory issues. This study will test whether sensory augmentation has the potential to improve post-stroke balance. Sensory augmentation is a method by which non-invasive vibration is used to enhance the sensory information available to users, which may make it easier to feel where they are and prevent losses of balance.

Подробное описание

The objective of this study is to design a novel multisensory augmentation approach to improve the control of standing balance in people with chronic stroke. With sensory augmentation, artificial feedback provides the nervous system with information about the dynamic state of the body, which can be used to prevent losses of balance. This clinical trial will investigate whether multisensory augmentation produces sustained balance improvements when applied as a training device. These potential improvements will be assessed by comparing the results of clinical and biomechanical assessments before and after a 10-week balance training program, in which half of the participants will be randomly assigned sensory augmentation.

Вмешательства

• Поведенческое Balance training with sensory augmentation
  Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, sensory augmentation will be delivered with an intensity controlled in real-time by their center of pressure motion. The difficulty of the balance training task will progressively increase over successive training sessions.
• Поведенческое Balance training
  Participants will complete 20 balance training sessions, in which they are required to keep their balance while standing on a platform that translates under their feet. During training, no sensory stimulation will be delivered. The difficulty of the balance training task will progressively increase over successive training sessions.

Первичные конечные точки

• Berg Balance Scale score change [Срок оценки: Before and after a 10-week period of balance training]

Вторичные конечные точки (4)

• Limits of Stability score (paretic direction) [Срок оценки: Before and after a 10-week period of balance training]
• Limits of Stability score (non-paretic direction) [Срок оценки: Before and after a 10-week period of balance training]
• Mediolateral center of pressure displacement [Срок оценки: Before and after a 10-week period of balance training]
• Mediolateral center of pressure velocity [Срок оценки: Before and after a 10-week period of balance training]

Критерии участия

Критерии включения

• Age of at least 21 years;
• Experience of a stroke at least 6 months prior to participation;
• Berg Balance Scale score less than 52
• Ability to stand independently for at least 1 minute without wearing an AFO or other brace that would preclude delivery of stimulation to the ankle or foot sole
• 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
• Pre-existing neurological disorders or dementia
• Severe visual impairment
• History of DVT or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions

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

• Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston

Идентификаторы

NCT: NCT05760885 · A4545-R · I01RX004545

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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