Effect of Home Based Transcranial Direct Current Stimulation (tDCS) With Exercise on Upper and Lower Limb Motor Functions in Chronic Stroke
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 4, 2019
CompletedFirst Submitted
Initial submission to the registry
January 9, 2020
CompletedFirst Posted
Study publicly available on registry
January 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2020
CompletedJune 16, 2020
June 1, 2020
6 months
January 9, 2020
June 13, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
20 minutes
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.
20 minutes
Secondary Outcomes (4)
Five-times Sit to Stand Test
5 minutes
6-Meter Walk Test
5 minutes
Timed Up and Go Test
5 minutes
Muscle strength
15 minutes
Study Arms (2)
Dual-tDCS & home program exercise
ACTIVE COMPARATORDual 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-tDCS & home program exercise
SHAM COMPARATORSham 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).
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty ofPhysical Therapy, Mahidol University
Salaya, Nakonpathom, 73170, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2020
First Posted
January 13, 2020
Study Start
October 4, 2019
Primary Completion
April 12, 2020
Study Completion
June 4, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share