An interventional study of Anodal tDCS cerebellar stimulation group and Anodal tDCS cerebral (M1) stimulation group in Stroke, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-03.
Sponsored by Riphah International University · Not applicable, Interventional, and Treatment
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
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 66 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
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Exclusion Criteria:
Anodal tDCS cerebellar stimulation
Other: Anodal tDCS cerebellar stimulation group
Anodal tDCS cerebral (M1) stimulation
Other: Anodal tDCS cerebral (M1) stimulation group
Sham: Single-session a-tDCS (2 mA, 20 min),
Other: sham group
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
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.
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.
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.
Time frame: Immediately after Intervention and then again after 1 hour.
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.
Time frame: Immediately after Intervention and then again after 1 hour.
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)
Time frame: Immediately after Intervention and then again after 1 hour.
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.
Time frame: 1 hour
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)
Time frame: Immediately after Intervention and then again after 1 hour.
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.
Time frame: Immediately after Intervention and then again after 1 hour.
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
Time frame: Immediately after Intervention and then again after 1 hour.
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.
Time frame: Immediately after Intervention and then again after 1 hour.
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.
Time frame: Immediately after Intervention and then again after 1 hour.
Plan to share: No
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Ran from Oct 2021 to primary completion in Sep 2022, 11 months.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's 11 months is below that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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