Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy (VRMT) and Transcranial Direct Current Stimulation (tDCS) to Improve Upper Limb Recovery in Patients with Stroke

Официальное название

Investigating the Efficacy of Combining Virtual Reality-Based Mirror Therapy and Transcranial Direct Current Stimulation to Improve Upper Limb Recovery in Patients with Stroke

Обзор

This study will investigate whether combining virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.

Подробное описание

More than half of stroke survivors suffer from upper-limb dysfunction that persists years after stroke, negatively impacting patients' independence and, therefore, affecting their quality of life. Motor rehabilitation is required after a stroke to facilitate motor recovery. More importantly, finding new ways to maximize patients' motor recovery is a core goal of stroke rehabilitation. Thus, researchers have explored the potential benefits of using advanced technologies such as virtual reality-based mirror therapy (VRMT) and transcranial direct current stimulation (tDCS) to boost the brain's responses to interventions and maximize the effects of rehabilitation to improve upper-limb recovery post-stroke. However, the potential impact of combining VRMT and tDCS on upper limb functions for patients with stroke has not been explored. Therefore, the goal of this study is to investigate whether combining virtual reality-based mirror therapy (VRMT) with transcranial direct current stimulation (tDCS) alongside conventional physical therapy (CPT) will significantly improve hand function for patients with stroke compared to using VRMT or tDCS alone.

The participants will be randomly assigned into one of the four groups: (1) the anodal tDCS + VRMT group, (2) the anodal tDCS alone group, (3) the VRMT alone with sham tDCS group, and (4) the CPT with sham tDCS group. All groups will receive CPT as part of the treatment. Functional scales will be used before and after the intervention to assess upper motor functions. These measures include the Fugl-Meyer Assessment, Wolf Motor Function Test, Box and Block Test, Nine-Hole Pegboard Test, and Stroke Impact Scale-16 (SIS-16). In addition, physiological measures such as transcranial magnetic stimulation (TMS) and task-based fMRI.

Вмешательства

• Устройство Transcranial Direct Current Stimulation
  tDCS will be used during the sessions. The anodal tDCS (2 mA) will be applied for 20 minutes. Continuous, direct currents. The anodal electrode will be positioned over the ipsilesional primary motor cortex (M1) (C3 or C4, international 10-20 system) of the affected hemisphere and the cathodal electrode over the contralateral orbit.
• Устройство Virtual reality
  The VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device.
• Устройство Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy
  20 minutes of tDCS during 45 minutes of VRMT games.
• Другое Conventional physical therapy
  45 minutes of conventional physical therapy with sham tDCS

Первичные конечные точки

• Fugl-Mayer Upper limb assessment (FMA) [Срок оценки: at baseline, and after 2 weeks, and after intervention ( 4 weeks).]
• Wolf motor function test (WMT) [Срок оценки: at baseline, and after 2 weeks, and after intervention ( 4 weeks).]
• box and blocks test (BBT) [Срок оценки: at baseline, and after 2 weeks, and after intervention ( 4 weeks).]
• Nine-Hole Peg Test (NHPT) [Срок оценки: at baseline, and after 2 weeks, and after intervention ( 4 weeks).]

Вторичные конечные точки (3)

• Stroke impact scale-16 (SIS-16) [Срок оценки: at baseline, and after 2 weeks, and after intervention ( 4 weeks).]
• transcranial magnetic stimulation (TMS) [Срок оценки: at baseline, and after intervention ( 4 weeks).]
• Functional magnetic resonance imaging (fMRI) [Срок оценки: at baseline, and after intervention ( 4 weeks).]

Критерии участия

Критерии включения

• At least 18 years old.
• Stroke patients with unilateral cerebral infarction or hemorrhage, more than three months following the stroke.
• Adequate cognitive ability to follow instructions (The Arabic version of the Mini-Mental State Examination scores > 24).
• Modified Ashworth scale score < 3.
• Fugl-Meyer Assessment (FMA) score of 10-58 indicating moderate-to-severe arm impairment.

Критерии исключения

• visual impairment and field defect or hemi-sensory inattention and unilateral neglect.
• Wernicke's aphasia, or global aphasia, leads to difficulty following instructions.
• Any contraindication to NIBS.
• Other neurological conditions or participation in another study.

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

Саудовская Аравия · 2 центра

• King fahad medical city — Riyadh
• King Khalid University Hospital — Riyadh

Идентификаторы

NCT: NCT06764797 · E-23-7496 · Not funded

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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