search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty ofPhysical Therapy, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active tDCS & PT

Sham tDCS & PT

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 8, 2019
Last Updated
January 9, 2020
Sponsor
Mahidol University
Collaborators
National Research Council of Thailand
search

1. Study Identification

Unique Protocol Identification Number
NCT04051671
Brief Title
Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke
Official Title
Effects of Dual-transcranial Direct Current Stimulation During Physical Therapy in Sub-acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
October 6, 2019 (Actual)
Study Completion Date
November 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
National Research Council of Thailand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS & PT
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham tDCS & PT
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
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 Outcome Measure Information:
Title
Five-Times-Sit-To-Stand test (FTSST)
Description
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.
Time Frame
5 minutes
Title
Timed Up & Go test (TUG)
Description
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.
Time Frame
5 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty ofPhysical Therapy, Mahidol University
City
Salaya
State/Province
Nakonpathom
ZIP/Postal Code
73170
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35428346
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs