Transcranial Direct Current Stimulation, Functional Activity, Stroke, RCT

Not Applicable

Completed

• Conditions: Ischemic Stroke; Hemorrhagic Stroke; Stroke, Cardiovascular

• Registration Number: NCT07200661
• Lead Sponsor: University of Phayao

Brief 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. 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

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.

Study Timeline

• Study Start: 2024-04-20
• Primary Completion: 2025-01-30
• Study Completion: 2025-01-30
• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Functional Mobility (TUG)	4 week	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.
Change in Functional Mobility (10MWT)	4 week	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.
Change in Functional Mobility ( 6MWT)	4 week	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.
Change in Functional Mobility (FTSST)	4 week	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.
Change in Functional Mobility (BBS)	4 week	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
Change in Functional Mobility (Fugl-Meyer Assessment (FMA))	4 week	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

Secondary Outcome Measures

Name	Time	Method
Change in Cognitive Function (Montreal Cognitive Assessment (MoCA))	4 week	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.
Change in Cognitive Function (Stroop test)	4 week	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.
Change in Cognitive Function (Digit Span)	4 week	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.

Trial Locations

Locations (3)

Mar Fah Luang university; 🇹🇭 Chiang Rai, Chiangrai, Thailand

Narongsak Khamnon; 🇹🇭 Chiang Rai, Tha Sut, Thailand

Chonticha Kaewjoho; 🇹🇭 Phayao, Thailand