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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Saud University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

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

    Device

    20 minutes of tDCS during 45 minutes of VRMT games.

  • Conventional physical therapy

    Other intervention

    45 minutes of conventional physical therapy with sham tDCS

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: anodal tDCS combined with VRMTExperimental treatment 1 intervention
Group B: Anodal tDCS aloneActive comparator 1 intervention
Group C: VRMT alone, Sham tDCSActive comparator 1 intervention
Group D: Conventional Physical therapy alone, Sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
at baseline, and after 2 weeks, and after intervention ( 4 weeks).
3

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.

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

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.

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

Secondary outcomes

1

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).

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

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.

Time frame
at baseline, and after intervention ( 4 weeks).
3

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.

Time frame
at baseline, and after intervention ( 4 weeks).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Saud University

Lead sponsor

King Fahad Medical City

Collaborator

King Saud Medical City

Collaborator