Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue

Официальное название

The Effects of Transcranial Direct Current Stimulation and Cognitive Behavioural Programme on Post-stroke Fatigue

Обзор

This study aims to evaluate the effect of transcranial direct current stimulation and cognitive behavioural programme on fatigue and its related outcomes among people with stroke.

Подробное описание

This study will adopt a randomized controlled trial. Participants will be randomized into one of the 3 groups. One group will receive transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. Another group will receive sham transcranial direct current stimulation and cognitive behavioural programme with home-based physical training. One group will receive home-based physical training only.

Вмешательства

• Комбинированный продукт tDCS & cognitive behavioral programme with home-based physical training
  Participants will receive 16 sessions of tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
• Поведенческое sham tDCS & cognitive behavioral programme with home-based physical training
  Participants will receive 16 sessions of sham-tDCS and 7 sessions of cognitive behavioral programme over 8 weeks and have physical training at home for 8 weeks.
• Поведенческое physical training
  Participants will have physical training at home for 8 weeks.

Первичные конечные точки

• Fatigue Assessment Scale [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]

Вторичные конечные точки (6)

• Pittsburgh Sleep Quality Index [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
• Geriatric Depression Scale [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
• Reintegration to Normal Living Index [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
• Cardio-ankle vascular index [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
• performance fatigue index [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]
• psychomotor vigilance task [Срок оценки: baseline, in the middle during the intervention, immediate post-intervention, 1- and 3-month after the completion of the intervention]

Критерии участия

Критерии включения

• diagnosed with stroke at least 6 months ago
• Fatigue Assessment Scale score ≥20
• cognitively intact

Критерии исключения

• Unstable medical conditions leading to fatigue
• Under any clinical trials
• with any other neurological diseases
• history of transient ischemic attack
• Contraindications to tDCS

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

Двойное слепое

Основная цель

Лечение

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Гонконг

Идентификаторы

NCT: NCT06810817 · HSEARS20240310002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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