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Ischemic StrokeNCT07200661

Transcranial Direct Current Stimulation, Functional Activity, Stroke, RCT

A study testing Experimental A tDCS: Transcranial direct current stimulation., Experimental B tDCS: Transcranial direct current stimulation. and Experimental C tDCS: Transcranial direct current stimulation. in people with Ischemic Stroke and Hemorrhagic Stroke, run by University of Phayao at 3 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke patients often experience impaired balance and weight-bearing due to muscle weakness and neurological deficits. Motor rehabilitation is a crucial goal in their recovery, and transcranial direct current stimulation (tDCS) has emerged as a promising therapeutic approach. Read more about this study

Who is it for?
Ages Up to 70 years
What is being tested?
Experimental A tDCS: Transcranial direct current stimulation., Experimental B tDCS: Transcranial direct current stimulation. and Experimental C tDCS: Transcranial direct current stimulation.
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
3 sitesThailand
Study dates
20 Apr 2024to 30 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Volunteers were diagnosed with cerebrovascular disease, aged 18 years and above, both male and female.
  • 1.1.2. Body mass index between 18.5-29.9 kg/m2 1.1.3. No history of falls in the 6 months prior to the study. 1.1.4. Able to follow instructions and consent to participate in the study. 1.1.5. Able to communicate with the researcher and provide information by themselves.
  • 1.1.6. Able to walk continuously for at least 10 meters safely.

Who cannot join

  • 1.2.1 Having undergone surgery to insert metal implants in the body, such as pacemakers, deep brain electrodes.
  • 1.2.2 High blood pressure, uncontrolled heart disease, or having underlying diseases, such as osteoarthritis, arthritis, such as gout, rheumatoid arthritis, severe and affecting treatment.
  • 1.2.3 Having a wound on the skull and abnormal sensation. 1.2.4 Having a history of injury or pain in the extremities. At a pain score of more than 5 out of a full score of 10, assessed by (Visual Analog Scale) 1.2.5 There is a condition of the inner ear that is disturbed, affecting balance, such as tinnitus.
  • 1.2.6. There are unresolved vision and hearing problems. 1.3 Criteria for withdrawing volunteers from the research 1.3.1 If a volunteer experiences pain or discomfort during the test, the test will be stopped and the volunteer will be removed from the research immediately.
  • 1.3.2 The volunteer requests to withdraw or is unwilling to continue the research.

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites
  • Mar Fah Luang university

    Chiang Rai, Chiangrai, 57100

  • Narongsak Khamnon

    Chiang Rai, Tha Sut, 57100

  • Chonticha Kaewjoho

    Phayao, 56000

Other trials in Thailand

About this study

Official title: The Effects of Transcranial Direct Current Stimulation on Improving Impairment and Functional Activity in Individuals With Stroke: A Randomized Controlled Trial

Stroke patients often experience impaired balance and weight-bearing due to muscle weakness and neurological deficits. Motor rehabilitation is a crucial goal in their recovery, and transcranial direct current stimulation (tDCS) has emerged as a promising therapeutic approach. When combined with motor training, tDCS can enhance walking and balance abilities. However, there is a lack of research exploring the combination of unstable surfaces training, cognitive function, and tDCS for stroke rehabilitation

Read the detailed description

Stroke is a leading cause of long-term disability worldwide, often resulting in impaired motor function, reduced walking ability, decreased muscle strength, and cognitive deficits. These limitations contribute to difficulties in activities of daily living, impaired balance, and reduced quality of life. Effective rehabilitation strategies are essential to promote functional recovery and reduce the risk of long-term dependence.

Transcranial direct current stimulation (tDCS) has emerged as a promising non-invasive neuromodulation technique to facilitate cortical excitability and enhance neuroplasticity in individuals with stroke. Anodal stimulation over the lesioned hemisphere has been shown to improve motor performance and cognitive processing, while sham stimulation does not induce comparable effects. Recent studies suggest that combining tDCS with task-specific rehabilitation programs may provide synergistic benefits by simultaneously enhancing neural activation and functional task performance.

Dual-task training, particularly stepping exercises performed on unstable surfaces, has been demonstrated to challenge both motor and cognitive systems simultaneously. This approach targets balance, gait adaptation, and executive function by requiring patients to divide attention between locomotion and cognitive demands. When applied in combination with tDCS, dual-task training may enhance neuroplasticity and strengthen functional outcomes beyond those achieved by conventional training alone.

The present randomized controlled trial is designed to investigate the combined effects of anodal tDCS and dual-task stepping exercise on unstable surfaces in stroke survivors. Participants will be randomized into three groups: (1) active tDCS combined with dual-task stepping, (2) dual-task stepping with sham tDCS, and (3) active tDCS alone. Interventions will be delivered three times per week for four weeks.

Primary outcomes will include measures of functional ability, walking speed, walking endurance, lower limb muscle strength, and cognitive ability. Secondary outcomes will explore the effects of combined stimulation on balance and overall motor recovery. It is hypothesized that participants receiving combined anodal tDCS and dual-task training will demonstrate greater improvements in both motor and cognitive outcomes compared with either intervention alone.

This study will contribute novel evidence to stroke rehabilitation research by addressing the knowledge gap regarding the integration of non-invasive brain stimulation with cognitive-motor dual-task training on unstable surfaces. The findings are expected to provide insights into effective multimodal rehabilitation strategies aimed at improving functional recovery and quality of life in stroke survivors.

Being tested
Experimental A tDCS: Transcranial direct current stimulation., Experimental B tDCS: Transcranial direct current stimulation., Experimental C tDCS: Transcranial direct current stimulation.
Keywords
Stroke, tDCS, Dual task training, Unstable surfaces, Cognitive function
Medical subject headings
Ischemic Stroke, Hemorrhagic Stroke, Myocardial Infarction, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental A tDCS: Transcranial direct current stimulation.Device

    Also called Unstable surface

    Group 1: Active tDCS combined with dual-task stepping (Experimental A) Participants in this group will receive anodal tDCS applied over the ipsilesional primary motor cortex (M1) at C3 or C4 (based on the 10-20 EEG system), with the reference electrode positioned over the contralesional supraorbital area. Stimulation will be delivered at an intensity of 2 mA for 20 minutes, During the stimulation period, participants will perform dual-task stepping exercises on unstable surfaces. The stepping program stepping on a foam pad (5 cm thick, 20 cm wide, 12 cm long). Each stepping session lasts 10 minutes and is immediately followed by overground walking at a comfortable speed for 10 meters, while simultaneously performing a cognitive task of counting backwards from 99 to 0. Participants are instructed not to pause or stop while performing the dual task. If they stop for more than 5 seconds, it is considered an error, which will be recorded.

  • Experimental B tDCS: Transcranial direct current stimulation.Device

    Also called Sham tDCS, Unstable surface

    Group 2:This group follows the same stepping and dual-task walking program as Group 1 (stepping on foam pad for 10 minutes, followed by overground walking with backward counting for 10 minutes). However, instead of active stimulation, participants receive sham tDCS.

  • Experimental C tDCS: Transcranial direct current stimulation.Device

    Group 3:Participants in this group will receive anodal tDCS only, without any dual-task or stepping training.

Study groups in NCT07200661
Study groupRoleWhat they receive
Dual talk with overground walking training + Unstable surface + tDCSExperimentalDual talk with overground walking training + Unstable surface + tDCS Volunteers received 10 min of unstable stepping training and 10 min of dual task overground walking training. After that, they received 20 min of transcranial direct current stimulation. Note; tDCS: Transcranial direct current stimulation.
Receives: Device: Experimental A tDCS: Transcranial direct current stimulation.
Dual talk with overground walking training + Unstable surface + tDCS (sham)Sham comparatorVolunteers received 10 min of unstable stepping training and 10 min of dual task overground walking training. After that, subjects were placed on the head with no electrical current applied for 20 min. Note; tDCS: Transcranial direct current stimulation.
Receives: Device: Experimental B tDCS: Transcranial direct current stimulation.
tDCS onlyExperimentalParticipants in this group will receive anodal tDCS only, without any dual-task or stepping training. Electrode placement and stimulation parameters are identical to Group 1 (anodal over ipsilesional M1, reference over contralesional supraorbital area, 2 mA, 20 minutes, with ramp-up and ramp-down). During stimulation, participants will remain seated and relaxed without additional motor or cognitive tasks. Total session duration: 20 minutes.
Receives: Device: Experimental C tDCS: Transcranial direct current stimulation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Functional Mobility (TUG)

    Balance control was measured using the Timed up and go test (TUGT). The tester measured the time it took the volunteers to stand up from a chair, walk straight ahead for 3 meters, turn around a cone, and walk back to sit in the chair at maximum speed and safety for 3 times. The average time taken by the volunteers in seconds was then calculated.

    Measured: 4 week

  2. Change in Functional Mobility (10MWT)

    Walking speed: The time taken to walk a distance of 10 meters (10-meter walk test: 10MWT) at normal and maximum speeds was measured. The tester measured the time taken for the 4 meters in the middle of the entire walkway. The test was repeated 3 times/speed and the average of each speed was calculated in meters/second. The movement was analyzed using a 2D (high-speed) motion analysis program.

    Measured: 4 week

  3. Change in Functional Mobility ( 6MWT)

    Functional endurance was measured using a 6-minute walk test (6MinWT) in which subjects walked as far as possible around a rectangular walkway. During the test, subjects were allowed to stand and rest without interrupting the test time. At the end of the test, the tester measured the distance covered by the subjects.

    Measured: 4 week

  4. Change in Functional Mobility (FTSST)

    Functional muscle strength test of the leg muscles using the Five times sit-to-stand test (FTSST) as quickly and safely as possible without using hands. The test was repeated 3 times and the average was calculated.

    Measured: 4 week

  5. Change in Functional Mobility (BBS)

    Berg Balance Scale (BBS), a healthcare provider gives a person 14 tasks, such as sitting to standing, standing unsupported, and reaching for objects, scoring their performance from 0 (unable to complete) to 4 (normal). The total score out of 56 indicates functional balance, with higher scores showing better balance and lower scores suggesting a greater risk of falling. The assessment takes about 15-20 minutes and requires simple equipment like a chair, stopwatch, and step stool

    Measured: 4 week

  6. Change in Functional Mobility (Fugl-Meyer Assessment (FMA))

    The Fugl-Meyer Assessment (FMA) assesses motor function, sensation, balance, joint range of motion, and joint pain, typically in stroke patients, using a standardized 3-point scale (0=cannot perform, 1=performs partially, 2=performs fully) for each item. An examiner observes the patient's ability to complete tasks and assigns scores for the upper extremity motor (66 points), lower extremity motor (34 points), sensation (24 points), balance (14 points), and joint pain and range of motion (44 points each). The final score, a number out of a possible 226, indicates the level of recovery, with higher scores signifying better functional ability

    Measured: 4 week

Secondary outcomes (3)
  1. Change in Cognitive Function (Montreal Cognitive Assessment (MoCA))

    MoCA, an examiner guides a patient through 10 minutes of tasks testing various cognitive domains, including attention, executive function, memory, language, and orientation, by having them copy a cube, draw a clock, remember words, name animals, and identify similarities between objects. The test is scored out of 30 points, with a score of 26 or higher generally considered normal.

    Measured: 4 week

  2. Change in Cognitive Function (Stroop test)

    the Stroop Test, measure and compare the time and accuracy for reading color words, naming colors in a non-conflicting way, and naming the color of ink in which an incongruent color word is printed.Color-Word Task: This is the main task where participants name the ink color of a color word that is printed in an incongruent color (e.g., the word "RED" in blue ink. The administrator records the number of correct responses within a set time (e.g., 45 seconds) or the total time to complete a set number of items.

    Measured: 4 week

  3. Change in Cognitive Function (Digit Span)

    Digit Span, a participant is asked to repeat sequences of numbers either in the original order (forward) or in reverse order (backward), with the sequence length increasing for correct repetitions.

    Measured: 4 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start20 Apr 2024
  3. Primary completion30 Jan 2025
  4. Study completion30 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized into three groups. Group A will receive active anodal tDCS (2 mA, 20 min) combined with dual-task stepping on unstable surfaces and overground walking with backward counting. Group B will perform the same dual-task stepping and walking but receive sham tDCS (device switched off after initial ramp-up). Group C will receive active anodal tDCS alone with no motor or cognitive tasks. Interventions will be conducted three times per week for four weeks, totaling 12 sessions. This design allows comparison of combined stimulation and training, training with sham stimulation, and stimulation alone to determine their relative effects on functional ability, walking speed, endurance, lower limb strength, and cognitive outcomes in stroke survivors. Intervention frequency: 3 sessions per week (Before and after each exercise session, volunteers' vital signs (blood pressure, oxygen saturation, heart rate) were measured.) Program length: 4 weeks
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200661
Sponsor's protocol ID
UPhayaoChonticha-219
Status last verified
Sep 2025
First submitted
11 Sep 2025
Last updated
1 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental A tDCS: Transcranial direct current stimulation., Experimental B tDCS: Transcranial direct current stimulation. and Experimental C tDCS: Transcranial direct current stimulation. in people with Ischemic Stroke and Hemorrhagic Stroke, run by University of Phayao at 3 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Functional Mobility (TUG) (time frame: 4 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.

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