Anodal TDCS and Postural Stability in Subacute Stroke
April 18, 2024 updated by: Riphah International University
Effects of Anodal Transcranial Direct Current Stimulation on Postural Stability in Sub-Acute Stroke
Stroke patients experience weakening of muscles on the affected side.
Damage to the motor cortex and the pyramidal tract due to a stroke leads to a motor control disorders and co-contraction of trunk muscles due to abnormal levels of abdominal muscle tension and voluntary movement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
TDCS is known to modulate motor excitability in humans and motor performance is crucial in postural control. Studies reports that applying anodal TDCS to the ipsilesional motor cortex improved motor functioning in which the Transcranial Direct Current Stimulation may have stimulated preserved areas of the motor cortex to enhance synaptic efficiency along the corticospinal tract.
Anodal TDCS has been shown to have immediate and short-term effects in stroke but its long-term effects in stroke are still unclear. Additionally, the available literature focuses on acute and chronic stages of stroke so we will target subacute stage of stroke. Therefore, this study is designed to investigate the short and long-term effects of Anodal Transcranial Direct Current Stimulation on postural stability in subacute stroke.
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan
- Pakistan Railway General Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ischemic stroke
- Sub-acute stroke
- Minimum score of 18 on PASS
Exclusion Criteria:
Hearing and Visual loss/ deficit
- Recurrent CVA
- Neurological condition affects the cognition
- Wound at skull
- Presence of shunt and/or metallic implant at cranial region
- Brain tumors
- Musculoskeletal conditions/ surgery in the lower extremities
- Cognitively compromised
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A
anodal Transcranial direct current stimulation with saline soaked sponges will be used on electrodes, for 20 mins in addition to the 60 mins of conventional treatment.
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The size of both electrodes will be 5cm x 5cm placed on the head with the anode on the primary motor cortex M1 of the affected side while the cathode on the contralesional eye.
The duration of the stimulation of anodal TDCS is 20 min and the intensity of current will be 2mA.
The ramp up and down period will be 30se each.
Treatment duration will be 5 times a week for 6 weeks for postural stability.
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Sham Comparator: Group B
A sham stimulation will be given.
It will be comprised 20 min of sham TDCS followed by 60 mins of conventional treatment for postural stability in sub-acute stroke
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postural training by visual feedback and weight shifting towards the non-paretic side. This program will have two phases. Phase one have 4 stages; The first stage (sessions 1-7), second stage (sessions 8-14), third stage (sessions 15-22), fourth stage (sessions 23-30). Next phase will include the exercises including balancing exercises. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postural Assessment Scale for Stroke Patients (PASS)
Time Frame: 12th week
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PASS evaluates the postural imbalance and functional abilities of patients with stroke in several conditions (lying on back, sitting, standing and while changing positions).
This scale is composed of 12 items.
Score can vary from 0 to 3, with 0 being the lowest level of functionality and 3 the highest; the total score be 36.
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12th week
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Trunk impairment scale (TIS) for Stroke Patients
Time Frame: 12th week
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It evaluates motor impairment of the trunk after stroke.
The TIS scores, on a range from 0 to 23, static and dynamic sitting trunkal stability as well as trunk coordination.
It also score the quality of trunk movement and to be a guide for treatment.
Number of items are 7, score of each item is 0-3.
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12th week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go Test (TUG)
Time Frame: 12th week
|
TUG test is a general performance test used to assess mobility, balance and locomotor performance in patients with balance disturbances.
The patients are asked to stand up from chair, walk to a line of 3 meters length at a normal pace, turn and walk back to the chair at your normal pace and sit down.
A patient whose score is less than 10 seconds is characterized as completely independent.
Assessment time will be at 0, 3rd, 6th,9th,12th week
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12th week
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Functional Reach Test (FRT)
Time Frame: 12th week
|
a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.
The patient is instructed to stand next to but not touching a wall and position the arm that is closer to the wall at 90 degrees of shoulder flexion with a closed fist.
The assessor records the starting position at the third metacarpal head on the yardstick.
Instruct the patient to reach as far as you can forward without taking a step.
The location of the third metacarpal is recorded.
Scores are determined by assessing the difference between the start and end positions in the reach distance usually measured in inches.
Three trials should be done and the average of the last two is noted.
Assessment time will be at 0, 3rd, 6th,9th,12th week
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12th week
|
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Stroke Specific Quality of life Scale (SS-QoL)
Time Frame: 12th week
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a reliable and valid tool for measuring self-reported health -related quality of life.
It is a patient centered outcome measure intended to provide an assessment of health-related quality of life specific with stroke.
Scale domains and items were derived from series of interviews with post stroke patients.
They must respond to each question of the SS-QOL with reference to the past week.
It contains 49 items in 12 domains: mobility, energy, upper extremity function (5 items), work/productivity (3 items ), mood (5 items), social roles (5 items),family roles (3 items ), language (5 items ), thinking (3 items), personality (3 items) higher scores indicate better functioning.
Assessment time will be at 0, 3rd, 6th,9th,12th week
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12th week
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mirza Obaid Baig, MSPT, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Saeys W, Vereeck L, Lafosse C, Truijen S, Wuyts FL, Van De Heyning P. Transcranial direct current stimulation in the recovery of postural control after stroke: a pilot study. Disabil Rehabil. 2015;37(20):1857-63. doi: 10.3109/09638288.2014.982834. Epub 2015 Jul 9.
- Halmi Z, Stone TW, Dinya E, Mally J. Postural instability years after stroke. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):105038. doi: 10.1016/j.jstrokecerebrovasdis.2020.105038. Epub 2020 Jun 23.
- Bornheim S, Croisier JL, Maquet P, Kaux JF. Transcranial direct current stimulation associated with physical-therapy in acute stroke patients - A randomized, triple blind, sham-controlled study. Brain Stimul. 2020 Mar-Apr;13(2):329-336. doi: 10.1016/j.brs.2019.10.019. Epub 2019 Oct 31.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 2, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
January 31, 2024
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 13, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Actual)
April 19, 2024
Last Update Submitted That Met QC Criteria
April 18, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC01353 Somia Shakeb
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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