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 (tDCS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Stroke Rehabilitaion
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy; Device: Transcranial Direct Current Stimulation; Device: Virtual reality; Other: Conventional physical therapy

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
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dr. Alaa M. Albishi, Assistant Professor; Phone Number: +966555090015; Email: aalbeshi@ksu.edu.sa
• Study Contact Backup: Name: Dr. Ahmad O Alokaily, Assistant Professor; Phone Number: +966557447442; Email: aalokaily@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 11461
    • Recruiting
    • King Khalid University Hospital
    • Contact: Dr. Taha Inam Dr. Taha Inam, Phd; Phone Number: +966548083373; Email: dr_taha_inam@hotmail.com
  • Riyadh, Saudi Arabia, 11461
    • Recruiting
    • King Fahad Medical City
    • Contact: Dr. Fahad alsubaie alsubaie, Phd; Phone Number: +966554728899; Email: falsubaie@kfmc.med.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anodal tDCS combined with VRMT; 20 minutes of anodal tDCS combined with 45 minutes of VRMT	Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy; 20 minutes of tDCS during 45 minutes of VRMT games.
Active Comparator: Anodal tDCS alone; 20 minutes of anodal tDCS alone	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.
Active Comparator: VRMT alone, Sham tDCS; 45 minutes of VRMT alone, For the sham-tDCS, the current flow will be terminated after 30 seconds.	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.
Sham Comparator: Conventional Physical therapy alone, Sham tDCS; 45 minutes of conventional physical therapy, For the sham-tDCS, the current flow will be terminated after 30 seconds.	Other: Conventional physical therapy; 45 minutes of conventional physical therapy with sham tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Mayer Upper limb assessment (FMA)	FMA is a performance-based impairment measure particular to strokes, designed to assess motor functioning, balance, sensory, and joint functionality. It consists of five domains, which have 155 total items. The full potential scale score is 226. Scale items are scored based on the ability to finish the item using a 3-point ordinal scale. Motor score: from 0 to 100, 66 points for the upper extremity and 34 points for the lower extremities.	at baseline, and after 2 weeks, and after intervention ( 4 weeks).
Wolf motor function test (WMT)	WMT, consisting of timed and practical tasks, measures the motor function of the upper extremity (UE). The WMFT has 17 items in the most common version. The first six items involved timed functional tasks; items 7 and 14 were strength tests, and the final nine analyzed the participants' movement quality while carrying out various tasks. Items scored on a 6-point scale, with lower scores indicating lower levels of functioning.	at baseline, and after 2 weeks, and after intervention ( 4 weeks).
box and blocks test (BBT)	BBT assesses manual dexterity of the hand. It requires subjects to lift and release 2.5 cm³ cubes to move them from one compartment to another. BBT comprises 150 blocks. The test should begin with the unaffected upper limb to practice and record baseline values. The score is defined as the number of blocks transferred correctly within 60 seconds.	at baseline, and after 2 weeks, and after intervention ( 4 weeks).
Nine-Hole Peg Test (NHPT)	NHPT was developed to assess finger dexterity. It is made up of a nine-peg square board. The board has holes on one end for the pegs to fit into, and it also has a shallow circular dish on the other for storing the pegs. The patient is instructed to quickly insert the pegs into the holes on the board after taking each one out of a container as part of the NHPT. Then, one by one, clients must bring the pegs out of the holes and put them back into the container. Scoring is according to how long it took them to finish the test activity, measured in seconds.	at baseline, and after 2 weeks, and after intervention ( 4 weeks).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke impact scale-16 (SIS-16)	SIS is a self-report health status measure specific to the stroke population. It consists of 16 items from the four physical domains (strength, hand function ADL/IADL, and mobility).	at baseline, and after 2 weeks, and after intervention ( 4 weeks).
transcranial magnetic stimulation (TMS)	TMS measures cortical excitability, which is non-invasive magnetic stimulation using brief-duration, fast-pulsating, or pulsed magnetic fields to induce electrical currents targeted at spatially separate parts of the cerebral cortex using a computerized, electromechanical medical device.	at baseline, and after intervention ( 4 weeks).
Functional magnetic resonance imaging (fMRI)	fMRI technique uses MRI technology to evaluate brain activity by looking for variations in blood flow. The coupling between cerebral blood flow and neuronal activation is the basis for this method. The participants will be trained on the task before the experimental session. A block design will be used in the fMRI scan; each fMRI scan lasts for 6 minutes, divided into six blocks with an interval of 30 seconds of task, 15 repeated contractions, each contraction lasting 2 seconds, interspersed with 30 seconds of rest.	at baseline, and after intervention ( 4 weeks).

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: King Fahad Medical City; King Saud Medical City
• Investigators: Principal Investigator: Alaa M. Albishi, Doctor of Philosophy, King Saud University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2023
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): July 21, 2025

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 2, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; Virtual reality, Mirror therapy, non invasive brain stimulation, tDCS, stroke
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: E-23-7496; Not funded (Other Identifier: Not funded)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No