Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke

Официальное название

Effects of FES-cycling in Patients With Hemiparesis After Stroke

Обзор

To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

Подробное описание

Design: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.

Setting: Neurologic Rehabilitation Unit Interventions: 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).

In addition to the assigned group treatment, subjects will perform their own standard rehabilitation program.

Participants will be evaluated before training, after training, and at 3 month follow-up visit

Вмешательства

• Устройство FES-cycling
  30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).
• Устройство SHAM-cycling
  30 minutes of active leg cycling with SHAM FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).

Первичные конечные точки

• VO2 peak at 2 months (L/min) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (5)

• Maximum power [Срок оценки: 2 months]
• Walking ability [Срок оценки: 4 months]
• quadriceps muscular thickness [Срок оценки: 2 months]
• Middle Cerebral Artery Blood Flow Velocity During Exercise [Срок оценки: 2 months]
• Cognitive function [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Adults with Hemiparesis after an unilateral first ever stroke
• Able to walk in security
• Time since stroke within 3 months to 1 year
• Sufficient cognitive function to understand and perform corresponding tasks

Критерии исключения

• Any history of neurological disorders or cardiovascular instability
• High spasticity on ankle, knee, hip muscles
• Inability to exercise on a cyclo-ergometer
• Pacemaker and other contraindications of the use of electrical stimulation

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• SMR Val Rosay — Saint-Didier-au-Mont-d'Or

Идентификаторы

NCT: NCT06230796 · 2023-01-VR · 2023-A00627-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗