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Anodal TDCS and Postural Stability in Subacute Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Anodal transcranial direct current stimulation
Sham Stimulation
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

45 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pakistan Railway General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Group A

Group B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Postural Assessment Scale for Stroke Patients (PASS)
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.
Trunk impairment scale (TIS) for Stroke Patients
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.

Secondary Outcome Measures

Timed Up and Go Test (TUG)
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
Functional Reach Test (FRT)
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
Stroke Specific Quality of life Scale (SS-QoL)
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

Full Information

First Posted
June 6, 2023
Last Updated
June 13, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05903599
Brief Title
Anodal TDCS and Postural Stability in Subacute Stroke
Official Title
Effects of Anodal Transcranial Direct Current Stimulation on Postural Stability in Sub-Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

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
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Anodal transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural Assessment Scale for Stroke Patients (PASS)
Description
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.
Time Frame
12th week
Title
Trunk impairment scale (TIS) for Stroke Patients
Description
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.
Time Frame
12th week
Secondary Outcome Measure Information:
Title
Timed Up and Go Test (TUG)
Description
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
Time Frame
12th week
Title
Functional Reach Test (FRT)
Description
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
Time Frame
12th week
Title
Stroke Specific Quality of life Scale (SS-QoL)
Description
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
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Somia Shakeb, DPT
Phone
+92 340 0933082
Email
somiashakeb@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mirza Obaid Baig, MSPT
Phone
0092 333 2238706
Email
obaid.baig@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Railway General Hospital
City
Rawalpindi
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somia Shakeb, DPT
Phone
+92 340 0933082
Email
somiashakeb@gmail.com
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT
Phone
0092 333 2238706
Email
obaid.baig@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25401406
Citation
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.
Results Reference
background
PubMed Identifier
32807450
Citation
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.
Results Reference
background
PubMed Identifier
31735645
Citation
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.
Results Reference
background

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Anodal TDCS and Postural Stability in Subacute Stroke

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