Идёт набор NCT07643337

Impact of VNS With Rehab on Gait Post-Stroke

Без фазы С лечением Upper Limb Deficit Stroke Gait Rehabilitation Stroke

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: Vagus Nerve Stimulation Therapy.
Кому может быть актуально: Состояния в реестре: Upper Limb Deficit, Stroke Gait Rehabilitation, Stroke. Базовые параметры: 22 лет — 80 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 →

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Официальное название

The Impact of Vagus Nerve Stimulation Paired With Rehabilitation on Lower Limb and Gait Functions After Ischemic Stroke

Обзор

This is a prospective, double-blinded, randomized controlled study to evaluate the impact of Vagus Nerve Stimulation (VNS) therapy on lower limb function.

Подробное описание

Stroke is a major cause of disability worldwide and currently there is a lack of effective treatments to improve functional capacity of patients with long-term disability. Vagus Nerve Stimulation (VNS) is FDA-approved for rehabilitation of upper limb deficits in patient with stroke. The device (including Vagus nerve electrodes and chest generator) is permanently implanted prior to the beginning of rehabilitation as standard of care. It is activated by patients and physical therapists during a period of 4.5 months of in-clinic and home therapy. However, so far there have been no approved neuromodulation treatments to improve lower limb functions and gait, which are key for patients' quality of life and their ability to integrate with work and social cycles.

This project will evaluate the impact of VNS on lower limb functions as measured by clinical and laboratory-based analyses of gait in stroke survivors. Patients with both upper and lower limb deficits will be included in this project. After the completion of the standard upper limb VNS-rehabilitation protocol, patients will be double-blindly randomized into 2 groups: a) lower limbs and gait rehabilitation with VNS ON for the duration of therapy; b) lower limbs and gait rehabilitation with VNS OFF.

Based on prior experience with upper limb deficits, we hypothesize that rehabilitation therapy coupled with VNS neuromodulation will elicit functional improvements in lower limb deficits and gait.

Вмешательства

Устройство Vagus Nerve Stimulation Therapy
Implanted vagus nerve stimulation (VNS) therapy for post-stroke recovery (Vivistim System, MicroTransponder, Austin, TX, USA)

Первичные конечные точки

Absolute Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - Fugl-Meyer Lower Extremity (FMA-LE) scale [Срок оценки: 90 days post-operation]

Вторичные конечные точки (12)

Absolute Change in Functional Assessment - 10-meter walk [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - 10-meter walk [Срок оценки: 90 days post-operation]
Absolute Change in Functional Assessment - 6-minute walk [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - 6-minute walk [Срок оценки: 90 days post-operation]
Absolute Change in Functional Assessment - Berg Balance Scale [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - Berg Balance Scale [Срок оценки: 90 days post-operation]
Absolute Change in Functional Assessment - Five Times Sit-to-Stand Test [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - Five Times Sit-to-Stand Test [Срок оценки: 90 days post-operation]
Absolute Change in Functional Assessment - Stroke Impact Scale [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - Stroke Impact Scale [Срок оценки: 90 days post-operation]
Absolute Change in Functional Assessment - 3D Motion Analysis of Gait [Срок оценки: 90 days post-operation]
Percent Change in Functional Assessment - 3D Motion Analysis of Gait [Срок оценки: 90 days post-operation]

Критерии участия

Критерии включения

Approved for Vagus Nerve Stimulation (VNS) and rehabilitation therapy
≥22 years and ≤ 80 years
Only patients who elect to undergo VNS therapy for stroke-related upper limb deficits
Residual active movement in the affected limb's thumb and other 2 fingers
Stroke-related deficits in the lower limbs and gait with a Functional Ambulation Category (FAC) ≥3
Able to follow simple instructions and independently walk short distances with or without external support or leg orthoses, but without manual contact with another person