Efficacy of Immersive Virtual Reality Combined With Stationary Cycling on Gait in Individuals With Stroke

Обзор

The purpose of this study is to evaluate whether an intervention based on immersive virtual reality combined with stationary cycling, in addition to neurological physiotherapy, improves gait in individuals with stroke. The study will also assess the effects of this intervention on balance, coordination, motor function, muscle tone, and participants' and therapists' satisfaction. The main questions this study aims to answer are: * Does immersive virtual reality combined with stationary cycling improve gait compared with neurological physiotherapy alone? * Does this combined intervention improve balance, coordination, motor function, and muscle tone in individuals with stroke? * How do participants and therapists perceive the use of immersive virtual reality combined with stationary cycling during rehabilitation? Researchers will compare a program that combines immersive virtual reality and stationary cycling with neurological physiotherapy to a neurological physiotherapy program alone. Participants will: * Take part in two intervention periods, with a total of 16 sessions over 8 weeks (two sessions per week). * Receive intervention sessions that include immersive virtual reality combined with stationary cycling and neurological physiotherapy, or neurological physiotherapy alone, depending on the intervention period. * Complete assessments of gait, balance, and motor function at baseline, after the first intervention period, and after the second intervention period.

Вмешательства

• Другое Neurological Physiotherapy intervention (NP).
  The Neurological Physiotherapy intervention (NP) will include 60-minute sessions structured into six therapeutic blocks: gait training; trunk control; balance, righting and stepping reactions; lower limb strengthening; stretching of the affected lower limb; and sensory stimulation of the affected foot. Each block will last approximately 5 to 15 minutes per session, depending on the individual needs of the participant.
• Устройство Virtual Reality Combined with Stationary Cycling intervention (VR-SC)
  The Virtual Reality Combined with Stationary Cycling intervention (VR-SC) will include 15 to 30 minutes of immersive virtual reality using the HOLOFIT VR Fitness software combined with stationary cycling, in addition to 30 minutes of neurological physiotherapy intervention (NP). Due to the reduced time allocated to NP, each therapeutic block will last approximately 2 to 10 minutes per session, depending on the individual needs of the participant. The VR-SC intervention will be delivered in five

Первичные конечные точки

• Qualitative Gait Assessment [Срок оценки: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).]
• Quantitative Gait Assessment [Срок оценки: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).]

Вторичные конечные точки (3)

• Balance [Срок оценки: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).]
• Motor Function [Срок оценки: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).]
• Spasticity [Срок оценки: The research team will conduct assessments at baseline, after the first intervention period (4 weeks after baseline), and after the second intervention period (12 weeks after baseline).]

Критерии участия

Критерии включения

• Men and women aged 18 years or older with a medically documented diagnosis of hemorrhagic or ischemic stroke.
• At least 6 months post-stroke.
• Presence of hemiparesis.
• Mild to moderate balance impairment, defined as a Berg Balance Scale score < 50.
• Gait impairment, defined as a Wisconsin Gait Scale score > 20.
• Preserved active movement in the lower limbs and ability to mount and remain seated on the stationary bicycle.

Критерии исключения

• Severe cardiac conditions.
• Visual or auditory impairments limiting the use of virtual reality head-mounted displays.
• Medical history of epilepsy.
• Severe attentional impairment or inability to cooperate with the study intervention.
• Severe cognitive impairment and marked difficulties in comprehension.
• Severe vestibular disorders and predisposition to dizziness or vomiting.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07529665 · SICEIA-2025-003245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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