Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects

Официальное название

Using Immersive Virtual Reality for the Upper Limb Rehabilitation of Post-stroke Subjects: a Multicenter Randomized Control Trial

Обзор

Stroke produces brain damages that results in sensory, motor, and cognitive impairments which reduce the patient's quality of life and social participation. Upper limb recovery is a complex process whose goal is to allow the patients to gain, in part or completely, independence in daily living activities, for that it represents one of the most important rehabilitation focus. Virtual reality is a fairly recent approach able to simulate concrete movements and functional tasks in a higher dosage compared to other therapies. It seems that the use of VR could improve limb function, however, the amount of this gain is still unclear because of insufficient evidence. This study aims at quantitatively investigating the effectiveness of an HMD immersive virtual reality system on the upper limb functioning in subacute stroke survivors.

Вмешательства

• Устройство Virtual Reality
  Four tasks, uni and bi-manuals, will be proposed for the treatment of the patient's paretic upper limb in virtual-apartment for improving the relevance and the transferability of the movements requested.

Первичные конечные точки

• Changes in upper limb impairment [Срок оценки: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)]

Вторичные конечные точки (8)

• Change in Spasticity [Срок оценки: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)]
• Change in Activities of Daily Living [Срок оценки: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)]
• Change in perceived quality of life [Срок оценки: Score changes before (T0) and after (T1) the 4 weeks of treatment and at 6-month follow-up (T2)]
• Kinematic data [Срок оценки: Parameters changes (e.g. hand peak velocities) before (T0) and after (T1) the 4 weeks of treatment]
• Electroencephalogram [Срок оценки: Data changes before (T0) and after (T1) the 4 weeks of treatment (4 weeks) and at 6-month follow-up (T2)]
• Treatment satisfaction [Срок оценки: After 4 weeks]
• Embodiment [Срок оценки: After 4 weeks]
• Cybersickness [Срок оценки: After 4 weeks]

Критерии участия

Критерии включения

• diagnosis of first, ischemic or hemorrhagic, stroke verified by brain imaging within 4 week
• upper limb motor impairment defined by an upper extremity score <55 on the Fugl-Meyer Assessment

Критерии исключения

• neurological conditions in addition to stroke that may affect motor function
• other medical conditions likely to interfere with the ability to safely complete the study protocol
• impaired cognitive functioning that influences the ability to give informed consent
• severe neuropsychological disorders
• visual impairment
• severe upper-limb pain defined as > 7 on the Visual Analogue Scale

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

Италия · 1 центр

• Ferrara University Hospital — Ferrara

Идентификаторы

NCT: NCT06892886 · VR_STROKE_MULTICENTER

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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