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Набор скоро начнётся NCT07203937

Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke

Без фазы С лечением Stroke Post-stroke Depression Post-stroke Anxiety Post-stroke Fatigue

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: RoboGait® Robotic Gait Training, Treadmill Walking Training.
Кому может быть актуально
Состояния в реестре: Stroke, Post-stroke Depression, Post-stroke Anxiety, Post-stroke Fatigue. Базовые параметры: 18 лет — 75 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
Список центров уточняется — проверьте первичный протокол.
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

Effects of Combined Robotic and Conventional Lower Limb Rehabilitation on Quality of Life, Depression, Anxiety, and Fatigue After Stroke: A Randomized Controlled Trial

Обзор

Stroke is a major cause of long-term disability and is often associated with reduced quality of life, depression, anxiety, and fatigue. Rehabilitation plays a key role in recovery, and robotic-assisted gait training provides intensive, repetitive, and individualized therapy. However, its effects on psychological outcomes and quality of life are not fully established. This randomized controlled trial will compare conventional rehabilitation combined with robotic-assisted gait training to conventional rehabilitation combined with treadmill training in stroke survivors. Both groups will receive treatment 5 days per week for 6 weeks. Assessments will be conducted at baseline, after 6 weeks of treatment, and at 3 months after treatment. The primary outcome is quality of life. Secondary outcomes include depression, anxiety, and fatigue. The results of this study will provide new evidence on the benefits of robotic rehabilitation for improving both physical and psychological well-being after stroke.

Вмешательства

  • Устройство RoboGait® Robotic Gait Training
    RoboGait® is a robotic lower limb orthosis system with adjustable dynamic body weight support, synchronized treadmill, and biofeedback software. Participants will receive robotic-assisted gait training 2 days per week for 6 weeks, in addition to conventional rehabilitation 5 days per week.
  • Устройство Treadmill Walking Training
    Participants will receive treadmill walking sessions 2 days per week for 6 weeks, combined with conventional rehabilitation 5 days per week. The treadmill sessions will be matched in duration and intensity to the robotic training sessions in the experimental arm.

Первичные конечные точки

  • Stroke-Specific Quality of Life Scale (SS-QoL) [Срок оценки: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
Вторичные конечные точки (3)
  • Fatigue Severity Scale (FSS) [Срок оценки: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
  • Hospital Anxiety and Depression Scale (HADS) - Anxiety Subscale [Срок оценки: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]
  • Hospital Anxiety and Depression Scale (HADS) - Depression Subscale [Срок оценки: Baseline (T0), 6 weeks post-treatment (T1), and 3 months post-treatment (T2)]

Критерии участия

Критерии включения

  • Age between 18 and 75 years
  • History of ischemic or hemorrhagic stroke at least 3 months prior to enrollment
  • Mini Mental State Examination (MMSE) score of 24 or higher
  • Modified Ashworth Scale score < 2 in the lower extremities

Критерии исключения

  • Severe cognitive or communication impairment
  • Mobility limitations due to joint contracture or deformity
  • Presence of open wounds or pressure ulcers
  • Uncontrolled hypertension or orthostatic hypotension
  • Severe cardiovascular disease, heart failure, cancer, or significant pulmonary disease
  • High fracture risk due to severe osteoporosis
  • Ambulation difficulty caused by lower extremity musculoskeletal disorders
  • Severe psychosis or neurosis
  • Modified Ashworth Scale score > 3 in the lower extremities

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
Простое слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Haolin T, Yuanbin Y, Hu Z, Wenjing Z, Jing Z, Jingfeng T, Long HE, Xuechao LI, Qinxuan S, Mei S. Efficacy of Daoyin combined with lower limb robot as a comprehensive rehabilitation intervention for stroke patients: a randomized controlled trial. J Tradit Chin Med. 2024 Jun;44(3):530-536. doi: 10.19852/j.cnki.jtcm.20240322.002. PMID 38767637
  • den Brave M, Beaudart C, de Noordhout BM, Gillot V, Kaux JF. Effect of robot-assisted gait training on quality of life and depression in neurological impairment: A systematic review and meta-analysis. Clin Rehabil. 2023 Jul;37(7):876-890. doi: 10.1177/02692155231152567. Epub 2023 Jan 22. PMID 36683416
  • Mustafaoglu R, Erhan B, Yeldan I, Gunduz B, Tarakci E. Does robot-assisted gait training improve mobility, activities of daily living and quality of life in stroke? A single-blinded, randomized controlled trial. Acta Neurol Belg. 2020 Apr;120(2):335-344. doi: 10.1007/s13760-020-01276-8. Epub 2020 Jan 28. PMID 31989505

Идентификаторы

NCT: NCT07203937 · E-60116787-020-695640

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗