Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation (tDCS) vs Anodal Cerebral tDCS
NCT Number: NCT06525129
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Cerebellar stimulation group (CbSG)|OTHER: Cerebral (M1) Stimulation group (MSG)|OTHER: Sham Stimulation group (SSG)
Sponsor: Riphah International University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-07
Completion Date: 2024-12

Summary:
To investigate which one of the two cerebellar and cerebral stimulation in comparison to sham stimulation is more effective in enhancing balance and postural stability in stroke patients

Primary Outcome Measures: Biodex balance system, The biodex balance system based specific dynamic postural tests were delineated for implementation on both static and dynamic levels. Postural stability tests were performed at three levels of stability: 12 (maximum stability = static), 7 (moderate stability) and 3 (slight stability)., 2 weeks|Berg balance scale, 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 the elderly population with impairment of balance and individuals with neurological disorders while sitting, standing, and transferring. This test included both static and dynamic type tasks. 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 was a stopwatch or watch with a second hand and a ruler or other indicator of 2, 5, and 10 inches., 2 weeks|Timed up and go test, 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., 2 weeks|Bestest balance evaluation system, 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 into 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), 2 weeks|TDCSs adverse effects questionnaire, Transcranial Direct-Current Stimulation (tDCS) adverse effects questionnaire:

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), 2 weeks