Набор скоро начнётся NCT06997744

TENS for Limb Function in Stroke: Design and Rationale for a Randomized Trial

Без фазы С лечением 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: Low-frequency(2HZ) TENS, High-frequency(100HZ) TENS, Placebo TENS.
Кому может быть актуально: Состояния в реестре: Stroke. Базовые параметры: 40 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: Китай
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

Comparative Effects of 2Hz Versus 100Hz Transcutaneous Electrical Nerve Stimulation on Upper Limb Motor Function Post-Stroke: Design and Rationale for a Randomized Trial

Обзор

This study tests whether slow or fast electrical nerve stimulation (TENS) works better to improve arm movement in people recovering from a stroke. Participants will receive TENS on their weak arm three times a week for eight weeks. The results will help find the best TENS setting to support stroke recovery.

Вмешательства

Устройство Low-frequency(2HZ) TENS
Participants receive transcutaneous electrical nerve stimulation (TENS) at a frequency of 2Hz. The stimulation is delivered using surface electrodes placed on the affected upper limb. Each session lasts 30 minutes and is conducted three times per week for a total of 8 weeks. Intensity is gradually increased from 1 mA to 3 mA during each session.
Устройство High-frequency(100HZ) TENS
Participants receive TENS at a frequency of 100Hz using the same electrode placement and schedule as the 2Hz group. Sessions last 30 minutes, three times weekly for 8 weeks, with intensity increasing from 1 mA to 3 mA across the session. This group represents high-frequency stimulation.
Устройство Placebo TENS
Participants use a TENS device identical in appearance to the active treatment units. The power light is on, but no electrical stimulation is delivered due to internal circuit disconnection. Sessions follow the same schedule and duration as the active groups.

Первичные конечные точки

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Срок оценки: Baseline, Week 4, Week 8, 1-month follow-up, and 3-month follow-up]

Вторичные конечные точки (4)

Manual Muscle Testing (MMT) for Wrist Flexion and Extension [Срок оценки: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up]
Modified Ashworth Scale (MAS) for Wrist Flexor Spasticity [Срок оценки: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up]
Lindmark Motor Score - Grasp Function Subscale [Срок оценки: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up]
Barthel Index [Срок оценки: Baseline, Week 4, Week 8, 1-month follow-up, 3-month follow-up]

Критерии участия

Критерии включения

Age 18 to 85 years
Clinical diagnosis of stroke (ischemic or hemorrhagic) within the past 10 days to 2 months
Presence of voluntary movement in the non-paretic arm and at least minimal antigravity movement in the paretic shoulder
At least 5 degrees of active wrist extension on the paretic side
Able to provide informed consent