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

Last updated: January 2, 2025
Sponsor: King Saud University
Overall Status: Active - Recruiting

Phase

3

Condition

Cerebral Ischemia

Stroke

Treatment

Conventional physical therapy

Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

Transcranial Direct Current Stimulation

Clinical Study ID

NCT06764797
E-23-7496
Not funded
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At least 18 years old.

  • Stroke patients with unilateral cerebral infarction or hemorrhage, more than threemonths following the stroke.

  • Adequate cognitive ability to follow instructions (The Arabic version of theMini-Mental State Examination scores > 24).

  • Modified Ashworth scale score < 3.

  • Fugl-Meyer Assessment (FMA) score of 10-58 indicating moderate-to-severe armimpairment.

Exclusion

Exclusion Criteria:

  • visual impairment and field defect or hemi-sensory inattention and unilateralneglect.

  • Wernicke's aphasia, or global aphasia, leads to difficulty following instructions.

  • Any contraindication to NIBS.

  • Other neurological conditions or participation in another study.

Study Design

Total Participants: 300
Treatment Group(s): 4
Primary Treatment: Conventional physical therapy
Phase: 3
Study Start date:
September 19, 2023
Estimated Completion Date:
July 21, 2025

Study Description

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.

Connect with a study center

  • King Khalid University Hospital

    Riyadh, 11461
    Saudi Arabia

    Active - Recruiting

  • King fahad medical city

    Riyadh, 11461
    Saudi Arabia

    Active - Recruiting

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