Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation (tDCS) vs Anodal Cerebral tDCS

Not Applicable

Not yet recruiting

• Conditions: Stroke
• Interventions: Other: Cerebral (M1) Stimulation group (MSG); Other: Cerebellar stimulation group (CbSG); Other: Sham Stimulation group (SSG)

• Registration Number: NCT06525129
• Lead Sponsor: Riphah International University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study Start: 2024-07
• Study First Submitted: 2024-07-24
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-29
• Last Update Posted: 2024-07-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• The study focused on individuals who had their first stroke,
• Additionally, participants needed to have a score of 6 or higher on the Johns Hopkins Fall Risk Assessment Tool (JHFRAT).
• The inclusion criteria mandated that participants must have the ability to give written consent, walk without any help, and
• have a functional condition that allows them to actively participate in the Biodex balancing training program.

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Exclusion Criteria

• Individuals with concurrent neurological problems such as Alzheimer's, Parkinson's, or cerebellar abnormalities,
• as well as those with psychological ailments, were excluded during the initial assessment phase.
• In addition, individuals who scored below 20 on the Mini Mental Status Examination Test (MMSE),
• displayed motor disorders that affected their ability to walk or use their lower limbs,
• were currently taking sedative medications, had amnesia, depression, radiculopathy, lumbar spinal cord root involvement, auditory or visual impairments, vertigo, recent fractures, severe cardiac problems,
• or had undergone electrotherapy that affected their nervous system within the past two weeks were also not included in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cerebral (M1) Stimulation group (MSG)	Cerebral (M1) Stimulation group (MSG)	-
Cerebellar stimulation group (CbSG)	Cerebellar stimulation group (CbSG)	-
Sham Stimulation group (SSG)	Sham Stimulation group (SSG)	-

Primary Outcome Measures

Name	Time	Method
Biodex balance system	2 weeks	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).
Berg balance scale	2 weeks	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.
Timed up and go test	2 weeks	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.
Bestest balance evaluation system	2 weeks	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)
TDCSs adverse effects questionnaire	2 weeks	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)