Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke

NCT04051671 | Completed

• 1 other identifier: MU-CIRB 2019/045.1102
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to evaluate the possible effect of using dual-tDCS applied during conventional physical therapy on lower limb function in stroke patients.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Five-Times-Sit-To-Stand test (FTSST)

  sling. Subjects will be instructed as the following "I want you to stand up and sit down 5 times as quickly as you can when I say 'Go'." Subjects must be fully standing between repetitions. Timing will begin at "GO" and ends when the patient's buttocks touch the seat after the fifth sit-to-stand.

  5 minutes

• Timed Up & Go test (TUG)

  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

Study Arms (2)

Active tDCS & PT

EXPERIMENTAL

Dual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy (about 1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Current intensity is fixed at 2 mA and current will flow continuously during 20. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors.

Device: Transcranial direct current stimulation

Sham tDCS & PT

ACTIVE COMPARATOR

Dual transcranial direct current stimulation (tDCS) will be applied over the leg motor area (M1) during the first 20 mins (sham mode) of conventional physical therapy (about 1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Physical therapist will give an intervention program exactly the same in all cases. The scope of intervention is administered to improve strength of weakened and postural lower limbs muscles such as trunk muscles, hip flexors/extensors/abductors, knee flexors/extensors.

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Dual Active/sham tDCS will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy. Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 2 weeks. The two experiments will be performed in random order for each subject.

Active 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 18-75 years.
• First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.
• Sub acute phase of stroke (less than 6 months)
• Able to sit-to-stand and stand-to-sit independently
• Able to walk without physical assistance at least 6 m
• Free of any neurological antecedent, unstable medical conditions or condition that may increase the risk of stimulation such as epilepsy

You may not qualify if:

• Pre-stroke disability
• Pregnant
• Be unable to understand the instruction
• No clear neurological antecedent history or psychiatric disorder
• Excessive pain in any joint of the paretic limb (numerical pain rating score \> 7)
• Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker
• Subjects are participating in the other protocol or receiving alternative treatment such as acupuncture

Sponsors & Collaborators

• Mahidol University: lead
• National Research Council of Thailand: collaborator

Study Sites (1)

Faculty ofPhysical Therapy, Mahidol University

Salaya, Nakonpathom, 73170, Thailand

Location

Related Publications (1)

• Klomjai W, Aneksan B. A randomized sham-controlled trial on the effects of dual-tDCS "during" physical therapy on lower limb performance in sub-acute stroke and a comparison to the previous study using a "before" stimulation protocol. BMC Sports Sci Med Rehabil. 2022 Apr 15;14(1):68. doi: 10.1186/s13102-022-00463-9.

  PMID: 35428346 DERIVED

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 Design

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

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: August 9, 2019
• Study Start: August 6, 2019
• Primary Completion: October 6, 2019
• Study Completion: November 6, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)