Thinking of joining a study?

Register your interest

NCT06764797 | RECRUITING | Stroke Rehabilitaion


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
Sponsor:

King Saud University

Information provided by (Responsible Party):

Dr. A.S. Outside Albishi

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.

Condition or disease

Stroke Rehabilitaion

Stroke

Intervention/treatment

Transcranial Direct Current Stimulation

Virtual reality

Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

Conventional physical therapy

Phase

PHASE3

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2023-09-19
Estimated Primary Completion Date : 2025-05-31
Estimated Study Completion Date : 2025-07-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.

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

Location Details

NCT06764797


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

Saudi Arabia, Riyadh Region

King fahad medical city

Riyadh, Riyadh Region, Saudi Arabia, 11461

RECRUITING

Saudi Arabia, Riyadh Region

King Khalid University Hospital

Riyadh, Riyadh Region, Saudi Arabia, 11461

Loading...