The Effects of Anodal and Cathodal tDCS Combined With Conventional Physical Therapy in Patients With Acute Stroke

NCT04577287 | Completed

• 1 other identifier: SI-2842019
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is thus to compare the effects 5 consecutive sessions of anodal and cathodal tDCS combined with conventional physical therapy on upper and lower limb motor performance in acute stroke at immediate, and 1-month followup.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (5)

• Fugl-Meyer Assessment

  gold standard and widely used tool to assess sensorimotor in stroke. The item from upper limb and lower limb section will be used. The items are rated on a 3-point ordinal scale as follows: 0 = unable to perform; 1 = partial ability to perform; and 2 = near normal ability to perform.

  20 minutes

• Wolf Motor Function Test

  The participants will be asked to perform 2 items that consist of reaching a can and reaching a pen because two tasks is the most common reaching task of hand functions in daily living activities.

  5 minutes

• Five Times Sit to Stand Test

  Subjects will sits on the chair and place their back against the chair. Timing will begin at "GO", the subjects will be asked to walk 3m, turn, walk back, and sit down. The stopwatch stops when the patient's buttocks touch the seat.

  5 minutes

• Time-up and go test

  The TUG test is a commonly used screening tool to measure basic mobility correlating to dynamic balance. Start from sitting, stand up, walk 3 meters, turn around, walk back 3 meters and sit down. Timed to complete the task represent the body transfer and gait performance

  5 minutes

• Muscle strength

  The strength of UE (shoulder flexor, shoulder extensor, elbow extensor, wrist extensor) and LE (hip extensor, hip flexor, knee extensor and ankle dorsiflexor) will be assessed by hand-held dynamometer

  10 minutes

Secondary Outcomes (1)

• Hemodynamic response (VMR%)

  15 minutes

Study Arms (2)

Cathodal tDCS & PT

EXPERIMENTAL

Cathodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hour). Cathode on the on the motor area (M1) of the affected hemisphere, anode on the supraorbital area of the unaffect hemisphere.Current intensity is fixed at 1.5 mA and current will flow continuously. Physical therapist will give an intervention program base on the same basic conventional physical therapy treatment. The scope of intervention is administered to improve motor functions and cerebral hemodynamic .

Device: Transcranial direct current stimulation

Anodal-tDCS & PT

EXPERIMENTAL

Anodal transcranial direct current stimulation (tDCS) will be applied for 20 mins before conventional physical therapy (about 1 hours). Anode on the motor are (M1) of the affected hemisphere, and cathodal on the supraorbital area of unaffected hemisphere. Current intensity is fixed at 1.5 mA and current will flow continuously. Physical therapist will give an intervention program base on the same basic conventional physical therapy treatment. The scope of intervention is administered to improve motor functions and cerebral hemodynamic .

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Cathodal/Anodal tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.

Anodal-tDCS & PT; Cathodal 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:

• Acute ischemic stroke patients who have aged between 18 and 75 years
• Having a first ever-ischemic stroke that are confirmed by MRI/CT scan
• Post stroke onset 2-10 days
• Be able to follow command
• Be able to walk with or without assistive device (Modified Ranking Scale ≤ 4)
• Free of any neurological antecedent or unstable condition (such as epilepsy) or cancer.
• Be able to initiate the upper limb movement

You may not qualify if:

• Recurrent stroke
• National Institute of Health Stroke Scale ≥ 20 points
• Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker
• Having excessive pain in any joint of the lower limb (numerical pain rating score \> 4/10)
• Having an open wound or wound infraction on scalp
• Having neglect or psychological diseases (such as schizophrenia, major depression)

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty ofPhysical Therapy, Mahidol University

Salaya, Nakonpathom, 73170, Thailand

Location

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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: October 1, 2020
• First Posted: October 6, 2020
• Study Start: October 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)