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Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke

Primary Purpose

Transcranial Direct Current Stimulation, Chronic 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 Transcranial Direct Current Stimulation focused on measuring transcranial direct current stimulation, motor function, exercise, chronic stroke

Eligibility Criteria

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

Inclusion Criteria:

  1. Aged between 18 and 75 years.
  2. First ischemic stroke.
  3. Stroke onset over 6 months to 5 years.
  4. Ability to communicate.
  5. Free of any neurological antecedent, unstable condition that may increase the risk of unsafe tDCS such as epilepsy.
  6. Unable to grasp normally (FMA-UE motor function on grasp score 0-1).
  7. Ability to walk 10 meters independently (with or without a mobility aid).
  8. Be able to follow the instruction.

Exclusion Criteria:

  1. Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker.
  2. Moderate pain in any joint of the lower limb (numerical pain rating score > 4/10).
  3. Open wound or wound infection on scalp.
  4. History of brain surgery.
  5. Musculoskeletal disorders affecting gait.
  6. Contracture or deformity of upper and lower extremity.

Sites / Locations

  • Faculty ofPhysical Therapy, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Dual-tDCS & home program exercise

Sham-tDCS & home program exercise

Arm Description

Dual transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered for 20 minutes before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks).

Sham transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered only 30 seconds before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks).

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment in upper & lower limbs
The assessment of motor function both upper and lower limbs, this study will measure only motor function domain from 5 domains includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. The 100 totally score divided into 66 points for upper limb and 34 points for lower limb.
Wolf Motor Function Test
This assessment quantifies upper limb motor ability through timed and functional tasks consists of 17 items. The scoring rated on a 6 points scale.

Secondary Outcome Measures

Five-times Sit to Stand Test
The five times sit to stand measure of functional lower limb muscle strength that quantifying functional change of transitional movement. Participants were asked to stand up and sit down as quickly as possible 5 times and keeping their arms folded across your chest. The researcher stop timing when the participant stands the 5th time.
6-Meter Walk Test
The assessment of walking speed in meters per second over short distance. The participants will be asked to walk 2 trials with comfortable speed for 10 meters. The researcher will time middle 6 meters.
Timed Up and Go Test
The assessment of functional mobility, balance, walking ability. The participants will be asked to walk with comfortable speed 3 meters, turn around the cone, walk back to the chair and sit down. The researcher will stop timing when the participant's buttocks touch the seat.
Muscle strength
The handheld dynamometer will be used to measure muscle strength. Participants will perform the action of muscle against the resistance 2 trials per muscle. The researcher will measure muscle strength of upper and lower limbs including wrist extensor, elbow extensor, ankle dorsiflexor, knee extensor, hip flexor, and hip extensor.

Full Information

First Posted
January 9, 2020
Last Updated
June 13, 2020
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT04226417
Brief Title
Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
Official Title
Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
October 4, 2019 (Actual)
Primary Completion Date
April 12, 2020 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

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 investigate the effect of home based dual tDCS combined with exercise on upper and lower limb motor functions in chronic ischemic stroke patients.
Detailed Description
Nowadays, stroke is the third cause of death in developing countries after coronary heart disease and cancer. Worldwide, 3 million women and 2.5 million men were killed by the stroke every year. In Thailand, stroke is the first leading cause of death. In every 2 minutes, Thai population have occurred at least one new stroke case. Over six months after stroke onset or chronic phase, long-term disability occurred when patients did not continuously receive appropriate intervention. Motor disability is the most limiting factor influencing activities in daily life, such as upper and lower limb motor functions, and gait disturbance, which could in turn leading to long-term disability. Especially, affected arm remains malfunction in half of chronic stroke patients. The multidisciplinary rehabilitation has been provided for chronic stroke patients to reduce burden of caregivers and to improve patients' well-being. Besides, many patients with chronic stroke who live in community could not access the hospital or health care center because of inconvenient transportation as well as limited support by the family. It past twenty years, transcranial direct current stimulation (tDCS) has been introduced as is non-invasive brain stimulation (NIBS) that can use in rehabilitation. There are several studies shown that tDCS can change cortical excitability in the brain and consider as an additional therapy to improve motor function in stroke patients. Moreover, the tDCS is portable, cost effective, safety to use and can be self-administered might benefit for patients in residence. In fact, imbalance of interhemispheric inhibition (IHI) occurred after stroke by neuronal excitability decreased in the lesioned hemisphere and increased in the non-lesioned hemisphere. The tDCS delivered weak direct current via two electrodes as anodal and cathodal. The effect of cathodal electrode can decrease excitability and increase excitability by anodal electrode. Furthermore, both electrodes were applied on the two hemisphere in the same period for expect the results of two electrode called dual tDCS. Current evidence indicated that the 4-week anodal tDCS combined transcranial direct current stimulation (tDCS) with robotic training could improve motor function in chronic stroke patients. Nevertheless, this intervention program is a hospital-based intervention, which would limit the generalization to patients who live in community. Previous study showed that 4-week anodal tDCS combined with exercise could improve upper and lower limb motor functions in chronic stroke patients. However, there is no evidence indicate that 4-week home-based tDCS combined with exercise have been improved upper and lower limb motor functions in chronic stroke patients in residence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Direct Current Stimulation, Chronic Stroke
Keywords
transcranial direct current stimulation, motor function, exercise, chronic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-tDCS & home program exercise
Arm Type
Active Comparator
Arm Description
Dual transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered for 20 minutes before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks).
Arm Title
Sham-tDCS & home program exercise
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation (tDCS) will be applied over C3-C4 by using a reference to the international 10-20 electrode placement system for EEG electrode placement. The current intensity will be 2 mA, delivered only 30 seconds before the home-based exercise program by themselves and/or caregiver. Anodal electrode will be applied over the M1 of the affected hemisphere, while the cathodal electrode will be applied over the M1 of the non-lesioned. In all sessions of intervention at participant's resident, the investigator will supervise the processes of setting tDCS and exercise in all sessions (total 12 sessions, 3 days per week for 4 weeks).
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
Dual/ Sham tDCS will be applied in 2 mA, 20 mins before the home-based exercise program in 3 times per week for 4 weeks (12 sessions)
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment in upper & lower limbs
Description
The assessment of motor function both upper and lower limbs, this study will measure only motor function domain from 5 domains includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand, hip, knee, and ankle. The 100 totally score divided into 66 points for upper limb and 34 points for lower limb.
Time Frame
20 minutes
Title
Wolf Motor Function Test
Description
This assessment quantifies upper limb motor ability through timed and functional tasks consists of 17 items. The scoring rated on a 6 points scale.
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Five-times Sit to Stand Test
Description
The five times sit to stand measure of functional lower limb muscle strength that quantifying functional change of transitional movement. Participants were asked to stand up and sit down as quickly as possible 5 times and keeping their arms folded across your chest. The researcher stop timing when the participant stands the 5th time.
Time Frame
5 minutes
Title
6-Meter Walk Test
Description
The assessment of walking speed in meters per second over short distance. The participants will be asked to walk 2 trials with comfortable speed for 10 meters. The researcher will time middle 6 meters.
Time Frame
5 minutes
Title
Timed Up and Go Test
Description
The assessment of functional mobility, balance, walking ability. The participants will be asked to walk with comfortable speed 3 meters, turn around the cone, walk back to the chair and sit down. The researcher will stop timing when the participant's buttocks touch the seat.
Time Frame
5 minutes
Title
Muscle strength
Description
The handheld dynamometer will be used to measure muscle strength. Participants will perform the action of muscle against the resistance 2 trials per muscle. The researcher will measure muscle strength of upper and lower limbs including wrist extensor, elbow extensor, ankle dorsiflexor, knee extensor, hip flexor, and hip extensor.
Time Frame
15 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: Aged between 18 and 75 years. First ischemic stroke. Stroke onset over 6 months to 5 years. Ability to communicate. Free of any neurological antecedent, unstable condition that may increase the risk of unsafe tDCS such as epilepsy. Unable to grasp normally (FMA-UE motor function on grasp score 0-1). Ability to walk 10 meters independently (with or without a mobility aid). Be able to follow the instruction. Exclusion Criteria: Presence of intracranial metal implantation, cochlear implant, or cardiac pacemaker. Moderate pain in any joint of the lower limb (numerical pain rating score > 4/10). Open wound or wound infection on scalp. History of brain surgery. Musculoskeletal disorders affecting gait. Contracture or deformity of upper and lower extremity.
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

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Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke

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