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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051671
• Other study ID #: MU-CIRB 2019/045.1102
• Status: Completed
• Phase: N/A
• Start date: August 6, 2019
• Est. completion date: November 6, 2019

Study information

• Verified date: January 2020
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 6, 2019
• Est. primary completion date: October 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age range 18-75 years.

2. First ever-ischemic lesion in the territory of middle cerebral artery or anterior cerebral artery. CT scan/MRI result is thus required.

3. Sub acute phase of stroke (less than 6 months)

4. Able to sit-to-stand and stand-to-sit independently

5. Able to walk without physical assistance at least 6 m

6. Free of any neurological antecedent, unstable medical conditions or condition that may increase the risk of stimulation such as epilepsy

Exclusion Criteria:

1. Pre-stroke disability

2. Pregnant

3. Be unable to understand the instruction

4. No clear neurological antecedent history or psychiatric disorder

5. Excessive pain in any joint of the paretic limb (numerical pain rating score > 7)

6. Presence of intracranial metal implantation, cochlea implant, or cardiac pacemaker

7. Subjects are participating in the other protocol or receiving alternative treatment such as acupuncture

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Transcranial direct current stimulation
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.

Locations

Country	Name	City	State
Thailand	Faculty ofPhysical Therapy, Mahidol University	Salaya	Nakonpathom

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	National Research Council of Thailand

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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