The Effect of The Ten-Session Dual-tDCS On Lower-Limb Performance in Sub- Acute and Chronic Stroke

NCT04687033 | Completed

• 1 other identifier: MU-CIRB 2019
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to determine the effect of the ten-session dual tDCS combine with physical therapy on gait performance, balance, and lower limbs muscle strength in patients with subacute and chronic stroke.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (5)

• Change from baseline gait speed at post-intervention

  Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

  immediately post-intervention

• Change from baseline gait speed at 1 week post-intervention

  Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

  1 week post-intervention

• Change from baseline gait speed at 1 month post-intervention

  Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

  1 month post-intervention

• Change from baseline gait speed at 2 month post-intervention

  Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

  2 month post-intervention

• Change from baseline gait speed at 3 month post-intervention

  Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany) will be used to analyze step length in centimeters (cm). Participants will walk 3 meters per trial on a platform and be assessed 5 times. The result will be selected from an average of five trials. Participants can rest between trials for about 2 minutes or as long as they desired to avoid fatigue.

  3 month post-intervention

Secondary Outcomes (30)

• Change from baseline spatiotemporal gait variable at post-intervention

  immediately post-intervention

• Change from baseline spatiotemporal gait variable at 1 week

  1 week post-intervention

• Change from baseline spatiotemporal gait variable at 1 month

  1 month post-intervention

• Change from baseline spatiotemporal gait variable at 2 months

  2 months post-intervention

• Change from baseline spatiotemporal gait variable at 3 months

  3 months post-intervention

Study Arms (2)

Dual-tDCS & PT

EXPERIMENTAL

Dual tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere for 20 mins before physical therapy (about 1 hour). The current intensity is fixed at 2 mA and the current will flow continuously. Physical therapist will give an intervention program for lower limb performance.

Device: Transcranial direct current stimulation

Sham-tDCS & PT

ACTIVE COMPARATOR

Sham tDCS: the anodal tDCS will be applied over the M1 of the lesioned hemisphere, while the cathodal tDCS will be applied over the M1 of the non-lesioned hemisphere, the current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performance.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

This instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down-regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2).

Dual-tDCS & PT; Sham-tDCS & PT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range 20-75 years
• First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. Diagnostic confirmation will be performed by CT scan or MRI
• Sub-acute onset (1-6 months after the stroke onset) or Chronic (6 months - 5 years)
• Able to walk without physical assistance at least 6 meters

You may not qualify if:

• Not cooperative or cannot understand the instruction
• Clinical unstable such as vital sign unstable (systolic blood pressure (SBP) ≥ 185 mmHg or diastolic blood pressure (DBP) ≥ 110 mmHg (98) and resting heart rate averaging ≥ 100 bpm (99))
• No clear neurological antecedent history or psychiatric disorder
• Moderate pain in any joint of both lower limb (Pain Scale (VAS) ≥ 4/10)
• Unstable medical conditions such as being in the middle of changing medical treatment.
• Condition that may increase the risk of stimulation such as epilepsy, pregnancy, unexplained headaches, intracranial metal, pacemaker (evaluating by subjective examination).
• Participate in the other protocol or receive alternative treatment such as transcranial magnetic stimulation within 1 month.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Mahidol University

Nakhon Pathom, 73170, Thailand

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Stroke; 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

• Wanalee Klomjai, PhD

  MU

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 29, 2020
• Study Start: January 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: August 1, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)