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

Official title

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

Overview

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.

Detailed 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.

Interventions

• Device 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.
• Device Virtual reality
  The VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device.
• Device Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy
  20 minutes of tDCS during 45 minutes of VRMT games.
• Other Conventional physical therapy
  45 minutes of conventional physical therapy with sham tDCS

Primary outcome measures

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

Secondary outcome measures (3)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Saudi Arabia · 2 centers

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗