The Effect of The Five-Session Dual-tDCS On Lower-Limb Performance in Sub-Acute Stroke

NCT04287231 | Completed

• 1 other identifier: MU-CIRB 2019/045.1102.1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (3)

• Force distribution measurement (FDM; The WinFDM and platform, Zebris Medical GmbH, Germany)

  Force distribution measurement (FDM) will be used to analyze gait cycle. The platform will be detecting the force and weight bearing when foot's patients contact the platform and calculate gait parameter. This system was used to analyze gait cycle (step length in cm, step time in second, speed in km/h and cadence in step/minute). Participants walked 3 meter per trial on platform and assessed 5 times. The result was selected from average five trials. Participants can rest between trials about 2 minutes or as long as they desired to avoid fatigue.

  15 minutes

• Timed-up and go test (TUG)

  The Timed-up \& Go (TUG) test is a simple and quick functional mobility test that requires a subject to stand up, walk 3 m, turn, walk back, and sit down. The objective of TUG is to determine fall risk and measure the progress of balance, sit to stand, and walking. This test was initially designed for elderly persons, but is used for people with Parkinson, stroke, Alzheimer, CVA, Huntington disease and others The TUG were assessed only 1 trial and participant were performed as comfortable speed. Materials of TUG are One chair with armrest, stopwatch, tape (to mark 3 meters). The patient starts in a seated position. After that the patient stands up upon therapist's command walks 3 meters, turns around, walks back to the chair and sits down. The time stops when the patient is seated and the subject is allowed to use an assistive device. Be sure to document the assistive device used.

  5 minutes

• Five Times Sit to Stand Test (FTSTS)

  The FTSTS measures the functional strength of the lower limbs. Subjects sat with their arms folded across the chest and their back against the chair's backrest. They were asked to stand up fully and sit down again 5 times as quickly as possible. The test was repeated 3 times The Five-Times-Sit-to-Stand test (FTSTS) is a clinical test that explores postural control and lower limb muscular strength, devised to accommodate patients who can perform the sit-to-stand activity at least five times. As such, it is a test helpful in quantifying a daily transitional movement while also helping to assess fall risk and disability The FTSTS were assessed 2 times and selected score of the best trial. Participants can rest between trials about 2 minutes or as long as they desire to avoid fatigue.

  5 minutes

Secondary Outcomes (1)

• Hand-held dynamometer (HHD)

  15 minutes

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 hours). Current intensity is fixed at 2 mA and current will flow continuously. Physical therapist will give an intervention program for lower limb performence.

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, current intensity will be 2mA (sham mode). Physical therapist will give an intervention program for lower limb performence.

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)
• Able to walk without physical assistance at least 6 meters

You may not qualify if:

• All subjects will be excluded from the study if they have:
• 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)

Faculty of Physical Therapy, Mahidol University

Salaya, Nakonpathom, 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: January 9, 2020
• First Posted: February 27, 2020
• Study Start: August 19, 2019
• Primary Completion: March 31, 2020
• Study Completion: July 31, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)