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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty ofPhysical Therapy, Mahidol University

Salaya, Nakonpathom, 73170, Thailand

About this study

Recently dual-tDCS applied before the conventional physical therapy show positive effect of lower limb performance. However to explore the time during which dual-tDCS can be combined with physical therapy to maximize motor performance is required. Results from the present study with be compared with our previous study that used dual-tDCS applied before physical therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 5 minutes

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.
Timed Up & Go test (TUG)

Time frame: 5 minutes

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.

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Collaborators

National Research Council of Thailand

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Aug 9, 2019
Registry last updated: Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed