Back to resultsSingle Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Anodal tDCS cerebellar stimulation group
Anodal tDCS cerebral (M1) stimulation group
sham group
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Transcranial Direct Current Stimulation, Anodal Cerebral
Eligibility Criteria
Inclusion Criteria:
- ability to give written consent.
- Able to walk unassisted
- Functional status allowing the participants to participate in the balance training.
- Score 6 or above on Johns Hopkins fall risk assessment tool
Exclusion Criteria:
- Neurological diseases, such as Parkinson, Alzheimer
- Any history of psychological illnesses
- Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
- Cerebellar disorders
- use of any sedative medicines in the two days prior to the study
- any symptoms of amnesia and depression;
- Memory disorders with scores below 21 on the Mini Mental Status Examination test
- Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
- Any signs of radiculopathy or root lumbar spinal cord involvement
- Any visual or auditory impairment, or vertigo reports
- Use of a heart rate regulator
- Any structural deformities in the lower extremities or the spine
- Any abnormalities in the vestibular system
- History of recent fracture
- Inability to move without assistance
Sites / Locations
- Akbar Hospital, Gujrat
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Sham Comparator
Arm Label
Anodal tDCS cerebellar stimulation group:
Anodal tDCS cerebral (M1) stimulation group:
Sham Group
Arm Description
Anodal tDCS cerebellar stimulation
Anodal tDCS cerebral (M1) stimulation
Sham: Single-session a-tDCS (2 mA, 20 min),
Outcomes
Primary Outcome Measures
Changes from the base line, Berg balance scale
Changes from the base line, Immediately after Intervention and then again after 1 hour. The Berg balance scale (BBS) is used to assess the participant's ability to retain stability. The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks; a total score of 56. Equipment required for this test were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches.
Timed Up and Go test
Changes from the base line, Immediately after Intervention and then again after 1 hour. The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall . The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis.
Balance Evaluation Systems Test
Changes from the base line, Immediately after Intervention and then again after 1 hour.. Balance Evaluation Systems Test (BESTest) is a 36-item assessment of balance impairments across 6 postural control contexts. Total score of 108 points total, calculated in to a percentage score (0-100%). Also total sub-scores exist for each above listed system. Item-level scores range from 0 (severe impairment) to 3 (no impairment)
Secondary Outcome Measures
Montreal cognitive Scale
Changes from the base line, Immediately after Intervention and then again after 1 hour. The tool used for cognitive impairment is Montreal Cognitive Assessment (MoCA). As there is not at all, fairly effective measuring tool for the early diagnosis of cognitive impairments. MoCA is a successful screening test used for the screening of mild cognitive impairment. Scores of MoCA ranges from 0-30.Interpretation of MoCA indicates that score of 26 and above normal, 18 -25 score indicates low cognitive impairments, 10 -18 score considered normal or moderate cognitive impairment while greater than 10 is considered to be severe cognitive impairments.
tDCS Adverse Effects Questionnaire :
Changes from the base line, Immediately after Intervention and then again after 1 hour.. Transcranial Direct-Current Stimulation (tDCS) adverse effects questionaire:
Do you experience any of the following symptoms or side- effects? Headache, Neck pain, Scalp pain, Tingling, Itching, Burning sensation, Skin redness, Sleepiness, Trouble concentrating, Acute mood change, Others (specify)
for each symptom patient can give value (1-4) (1, absent; 2,mild; 3, moderate; 4, severe)
If present: Is this related to tDCS? (1, none ; 2, remote; 3, possible; 4, probable; 5, definite)
6 min walk test: Distance (meters)
Changes from the base line, Immediately after Intervention and then again after 1 hour. 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Timed 25-Foot Walk test
Changes from the base line, Immediately after Intervention and then again after 1 hour. Timed 25-Foot Walk (T25-FW) test is a quantitative mobility and leg function performance test based on a timed 25-walk. Two trials will be given to the patient and time will be noted in seconds
Johns Hopkins fall risk assessment Tool
Changes from the base line, Immediately after Intervention and then again after 1 hour. Risk of falling was assessed using the Johns Hopkins Fall Risk Assessment score 13,14 ; a score of less than 6 is considered low risk, 6 to 13 is considered moderate risk, and greater than 13 is considered high risk.
Mini mental state examination (MMSE)
Changes from the base line, Immediately after Intervention and then again after 1 hour. Mini mental state examination (MMSE): used to screen for cognitive impairment in elderly. The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Full Information
NCT ID
NCT05129683
First Posted
September 23, 2021
Last Updated
August 1, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05129683
Brief Title
Single Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients
Official Title
Effects of a Single Session of Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Mobility and Cognition in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
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
Yes
5. Study Description
Brief Summary
To compare the effect of anodal cerebellar transcranial direct current stimulation (ctDCS) vs anodal cerebral direct current stimulation on balance, mobility and cognition in stroke patients in stroke patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Transcranial Direct Current Stimulation, Anodal Cerebral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anodal tDCS cerebellar stimulation group:
Arm Type
Experimental
Arm Description
Anodal tDCS cerebellar stimulation
Arm Title
Anodal tDCS cerebral (M1) stimulation group:
Arm Type
Experimental
Arm Description
Anodal tDCS cerebral (M1) stimulation
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Sham: Single-session a-tDCS (2 mA, 20 min),
Intervention Type
Other
Intervention Name(s)
Anodal tDCS cerebellar stimulation group
Intervention Description
Single-session atDCS (2 mA, 20 min). The active (anode) and the returning (cathode) electrodes will be placed bilaterally over the cerebellum (1 -2 cm below inion of occipital bone) and the right buccinator muscle, respectively Xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins will also be given
Intervention Type
Other
Intervention Name(s)
Anodal tDCS cerebral (M1) stimulation group
Intervention Description
single session a-tDCS (2 mA, 20 min), the anode will be positioned over the lesioned M1 (C3, International 10-20 system) and the cathode would be located over the supraorbital area. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.
Intervention Type
Other
Intervention Name(s)
sham group
Intervention Description
single session a-tDCS (2 mA, 20 min), Sham tDCS followed a similar protocol as Anodal tDCS cerebral (M1) stimulation and arrangement but stimulation for 30 s, after which the current was ramped-down and turned off for the rest of the treatment. xbox kinect based balance and mobility training using games from Xbox Adventure Pack for 50 mins.
Primary Outcome Measure Information:
Title
Changes from the base line, Berg balance scale
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. The Berg balance scale (BBS) is used to assess the participant's ability to retain stability. The BBS is a widely used test for the assessment of elderly population with impairment of balance and individuals with neurological disorder while sitting, standing, and transferring. This test included both static and dynamic type task. The BBS uses a five-point ordinal scale ranging from 0 (disability) to 4(complete independent performance) and consists of 14 components; the maximum score is 56 points. The scale has been shown to be reliable and valid in stroke patients. A cut-off score of 45 points is used for fall prediction. The BBS involves 14 tasks; a total score of 56. Equipment required for this test were a stop watch or watch with a second's hand and a ruler or other indicator of 2, 5, and 10 inches.
Time Frame
Immediately after Intervention and then again after 1 hour.
Title
Timed Up and Go test
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. The Timed Up and Go (TUG) test was designed for the evaluation of balance and Measures mobility in people who are able to walk on their own (assistive device permitted) to find out the risk of fall . The subjects will be required to stand up from a chair, walk 3 m, turn around, return to the chair, and sit down. The time taken to complete this task will be measured. The test will be informed three times. The time required to complete this task will be measured from a stopwatch. The average values from 3 trials, with 1-min rest between each trial, were used for data analysis.
Time Frame
Immediately after Intervention and then again after 1 hour.
Title
Balance Evaluation Systems Test
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour.. Balance Evaluation Systems Test (BESTest) is a 36-item assessment of balance impairments across 6 postural control contexts. Total score of 108 points total, calculated in to a percentage score (0-100%). Also total sub-scores exist for each above listed system. Item-level scores range from 0 (severe impairment) to 3 (no impairment)
Time Frame
Immediately after Intervention and then again after 1 hour.
Secondary Outcome Measure Information:
Title
Montreal cognitive Scale
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. The tool used for cognitive impairment is Montreal Cognitive Assessment (MoCA). As there is not at all, fairly effective measuring tool for the early diagnosis of cognitive impairments. MoCA is a successful screening test used for the screening of mild cognitive impairment. Scores of MoCA ranges from 0-30.Interpretation of MoCA indicates that score of 26 and above normal, 18 -25 score indicates low cognitive impairments, 10 -18 score considered normal or moderate cognitive impairment while greater than 10 is considered to be severe cognitive impairments.
Time Frame
1 hour
Title
tDCS Adverse Effects Questionnaire :
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour.. Transcranial Direct-Current Stimulation (tDCS) adverse effects questionaire:
Do you experience any of the following symptoms or side- effects? Headache, Neck pain, Scalp pain, Tingling, Itching, Burning sensation, Skin redness, Sleepiness, Trouble concentrating, Acute mood change, Others (specify)
for each symptom patient can give value (1-4) (1, absent; 2,mild; 3, moderate; 4, severe)
If present: Is this related to tDCS? (1, none ; 2, remote; 3, possible; 4, probable; 5, definite)
Time Frame
Immediately after Intervention and then again after 1 hour.
Title
6 min walk test: Distance (meters)
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. 6 min walk test was used to measure Functional capacity. It is a sub maximal exercise test which can aid in assessing functional capacity of patients with cardiopulmonary diseases, in this test we find out the maximum distance in meters which an individual covers in 6 min without any support.
Time Frame
Immediately after Intervention and then again after 1 hour.
Title
Timed 25-Foot Walk test
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. Timed 25-Foot Walk (T25-FW) test is a quantitative mobility and leg function performance test based on a timed 25-walk. Two trials will be given to the patient and time will be noted in seconds
Time Frame
Immediately after Intervention and then again after 1 hour.
Title
Johns Hopkins fall risk assessment Tool
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. Risk of falling was assessed using the Johns Hopkins Fall Risk Assessment score 13,14 ; a score of less than 6 is considered low risk, 6 to 13 is considered moderate risk, and greater than 13 is considered high risk.
Time Frame
Immediately after Intervention and then again after 1 hour.
Title
Mini mental state examination (MMSE)
Description
Changes from the base line, Immediately after Intervention and then again after 1 hour. Mini mental state examination (MMSE): used to screen for cognitive impairment in elderly. The maximum MMSE score is 30 points. A score of 20 to 24 suggests mild dementia, 13 to 20 suggests moderate dementia, and less than 12 indicates severe dementia.
Time Frame
Immediately after Intervention and then again after 1 hour.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ability to give written consent.
Able to walk unassisted
Functional status allowing the participants to participate in the balance training.
Score 6 or above on Johns Hopkins fall risk assessment tool
Exclusion Criteria:
Neurological diseases, such as Parkinson, Alzheimer
Any history of psychological illnesses
Receipt of electrotherapy that might affect the nervous system in the two weeks prior to the study
Cerebellar disorders
use of any sedative medicines in the two days prior to the study
any symptoms of amnesia and depression;
Memory disorders with scores below 21 on the Mini Mental Status Examination test
Any signs of severe motor disorders in the lower extremity which cause any movement limitation or deformity
Any signs of radiculopathy or root lumbar spinal cord involvement
Any visual or auditory impairment, or vertigo reports
Use of a heart rate regulator
Any structural deformities in the lower extremities or the spine
Any abnormalities in the vestibular system
History of recent fracture
Inability to move without assistance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad Nawaz Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akbar Hospital, Gujrat
City
Gujrāt
State/Province
Punjab
ZIP/Postal Code
50010
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Single Session of Anodal Cerebellar vs Cerebral Transcranial Direct Current Stimulation in Stroke Patients
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