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Идёт набор NCT07189819

Innovative Closed-loop Functional Electrical Stimulation Control System for Augmenting Post-stroke Gait

Без фазы С лечением Post-stroke Hemiparesis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES), Conventional Functional Electrical Stimulation (FES).
Кому может быть актуально
Состояния в реестре: Post-stroke Hemiparesis. Базовые параметры: 40 лет — 90 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

This study will compare the performance of a novel data-driven model-predictive controller (MPC) based functional electrical stimulation (FES) system versus a conventional FES system for footdrop correction during treadmill and overground walking tasks in people post-stroke.

Подробное описание

Functional electrical stimulation (FES) is a common rehabilitation tool that incorporates electrical stimulation timed with a functional task to augment paretic muscle function in people with neuro-pathologies such as stroke and spinal cord injury. The rigor of previous research has established the safety, as well as both neuro-prosthetic and therapeutic effects of FES systems for standing, walking, and grasping. Stroke is the leading cause of disability, and footdrop is a highly prevalent post-stroke gait deficit, leading to insufficient ankle dorsiflexion during the swing phase of gait, and contributing to reduced mobility. FES systems that correct footdrop to improve gait function and reduce fall risk are gaining popularity, with commercial systems such as enhancing translation potential. Despite their promising functional value, accessibility, and positive neuroplasticity effects, current FES systems have some fundamental limitations, which limit their clinical prescription.

The goal of this project is to overcome two major limitations and technical gaps in FES: rapid onset of muscle fatigue during FES and lack of sophisticated closed-loop control of FES intensity. Most existing FES systems do not automatically modulate stimulation intensity in response to muscle fatigue, and may overstimulate the muscles if fixed (open-loop) stimulation or a pure feedback-based stimulation strategy is used to control FES intensity. To address this limitation, the researchers aim to develop and clinically test FES for improving stroke gait using data-driven FES control systems.

Footdrop is a highly prevalent post-stroke gait deficit, leading to insufficient ankle dorsiflexion during the swing phase of gait, and reducing functional mobility. FES, which is an external application of stimulation to generate muscle contractions during a functional motor task, can achieve muscle force demands during standing and walking, and help persons with stroke and spinal cord injury recover mobility. FES for the correction of footdrop is one of the most popular gait applications of FES, which has been shown to improve mobility and reduce falls.

Although FES has positive effects on walking function, elicits active muscle contractions, and enhances corticomotor excitability, FES is not used as commonly as passive orthotics. Most current FES systems incorporate motion sensors to control the timing of FES during the gait cycle (paretic leg swing phase). However, none of these systems provide automatic closed-loop control of FES intensity, so that optimal stimulation can be delivered for each step, preventing over-stimulation, reducing fatigue, and maintaining optimal muscle performance for a greater number of steps. Additionally, rapid onset of muscle fatigue during FES is caused by synchronous, non-selective, repeated recruitment of largely fatigable muscle fibers.

The researchers will implement an innovative model-predictive controller (MPC) combined with real-time ultrasound-based feedback to deliver optimal FES intensities and minimize fatigue.

Вмешательства

  • Устройство Model-Predictive Controller (MPC) Functional Electrical Stimulation (FES)
    The model-predictive controller (MPC) determines the timing and intensity of electrical stimulation delivered for FES. MPC combined with real-time ultrasound-based feedback delivers optimal FES intensities and minimizes fatigue. FES is delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.
  • Устройство Conventional Functional Electrical Stimulation (FES)
    For functional electrical stimulation, surface electrodes are placed on the paretic leg on skin overlying the tibialis anterior (TA) muscle, with intensity pre-set to elicit dorsiflexion to neutral against gravity. FES will be delivered to the ankle dorsiflexor muscles using a commercially available FDA-approved electrical stimulator.

Первичные конечные точки

  • Number of Adverse Events [Срок оценки: Day 1]
  • Count of Risks [Срок оценки: Day 1]
  • Participant Perception of Comfort [Срок оценки: Day 1]
  • Participant Perception of Acceptability [Срок оценки: Day 1]
  • Percent of Gait Cycles with Footdrop Correction [Срок оценки: Day 1]
  • Number of Participants Completing Gait Bouts [Срок оценки: Day 1]
Вторичные конечные точки (3)
  • Peak Ankle Dorsiflexion Angle During Swing [Срок оценки: Day 1]
  • Overground Walking Distance [Срок оценки: Day 1]
  • FES Intensity [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • >6 months since stroke
  • cortical or subcortical stroke
  • able to walk 10-meters with or without an assistive device
  • sufficient cardiovascular health and ankle stability to walk on treadmill without ankle orthosis
  • passive ankle range of motion to benefit from dorsiflexor FES assistance
  • resting heart rate 40-100 bpm

Критерии исключения

  • cerebellar signs
  • score >1 on question 1b (does not know the current month and age) and >0 on question 1c (can not blink eyes and squeeze hands) on NIH Stroke Scale
  • inability to communicate with investigators
  • neglect/hemianopia
  • unexplained dizziness in past 6 months
  • sensory loss in paretic leg
  • musculoskeletal or medical conditions limiting walking
  • neurologic diagnoses other than stroke

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Emory Rehabilitation Hospital — Atlanta

Идентификаторы

NCT: NCT07189819 · STUDY00010102 · 1R21HD116484 · 2025P013785

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗