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

NCT06764797 | Recruiting Phase 3 DMC

• 2 other identifiers: E-23-7496Not funded
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

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.

Conditions

Stroke Rehabilitaion; Stroke

Keywords

Virtual reality, Mirror therapy, non invasive brain stimulation, tDCS, stroke; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Stroke impact scale-16 (SIS-16)

  at baseline, and after 2 weeks, and after intervention ( 4 weeks).

• transcranial magnetic stimulation (TMS)

  at baseline, and after intervention ( 4 weeks).

• Functional magnetic resonance imaging (fMRI)

  at baseline, and after intervention ( 4 weeks).

Study Arms (4)

anodal tDCS combined with VRMT

EXPERIMENTAL

20 minutes of anodal tDCS combined with 45 minutes of VRMT

Device: Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy

Anodal tDCS alone

ACTIVE COMPARATOR

20 minutes of anodal tDCS alone

Device: Transcranial Direct Current Stimulation

VRMT alone, Sham tDCS

ACTIVE COMPARATOR

45 minutes of VRMT alone, For the sham-tDCS, the current flow will be terminated after 30 seconds.

Device: Virtual reality

Conventional Physical therapy alone, Sham tDCS

SHAM COMPARATOR

45 minutes of conventional physical therapy, For the sham-tDCS, the current flow will be terminated after 30 seconds.

Other: Conventional physical therapy

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Anodal tDCS alone

Virtual reality DEVICE

The VRMT group will receive VRMT game-based training using their non-affected upper limb. using a semi-immersive motion-tracking device.

VRMT alone, Sham tDCS

Transcranial Direct Current Stimulation compined with virtual reality based mirror therapy DEVICE

20 minutes of tDCS during 45 minutes of VRMT games.

anodal tDCS combined with VRMT

Conventional physical therapy OTHER

45 minutes of conventional physical therapy with sham tDCS

Conventional Physical therapy alone, Sham tDCS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead
• King Fahad Medical City: collaborator
• King Saud Medical City: collaborator

Study Sites (2)

King fahad medical city

Riyadh, Riyadh Region, 11461, Saudi Arabia

RECRUITING

King Khalid University Hospital

Riyadh, Riyadh Region, 11461, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Alaa M. Albishi, Doctor of Philosophy

  King Saud University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Alaa M. Albishi, Assistant Professor

CONTACT

+966555090015; aalbeshi@ksu.edu.sa

Dr. Ahmad O Alokaily, Assistant Professor

CONTACT

+966557447442; aalokaily@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: September 19, 2023
• Primary Completion: May 31, 2025
• Study Completion: July 21, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

SA (2)