Clinical trial NCT06764797: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Stroke Rehabilitaion
Stroke
Keywords: Virtual reality, Mirror therapy, non invasive brain stimulation, tDCS, stroke
transcranial direct current stimulation
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: King Fahad Medical City
name: King Saud Medical City
First posted: 2025-01-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: Fugl-Mayer Upper limb assessment (FMA)
timeFrame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
measure: Wolf motor function test (WMT)
timeFrame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
measure: box and blocks test (BBT)
timeFrame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
measure: Nine-Hole Peg Test (NHPT)
timeFrame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
Secondary outcomes:
measure: Stroke impact scale-16 (SIS-16)
timeFrame: at baseline, and after 2 weeks, and after intervention ( 4 weeks).
measure: transcranial magnetic stimulation (TMS)
timeFrame: at baseline, and after intervention ( 4 weeks).
measure: Functional magnetic resonance imaging (fMRI)
timeFrame: at baseline, and after intervention ( 4 weeks).
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King fahad medical city
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
Study officials:
affiliation: King Saud University
name: Alaa M. Albishi, Doctor of Philosophy
role: PRINCIPAL_INVESTIGATOR
References: