Comparison of Multi-session Anodal Cerebellar Transcranial Direct Current Stimulation vs Anodal Cerebral Transcranial Direct Current Stimulation on Balance, Its Components and Postural Stability in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Biodex balance system
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Biodex balance system
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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)
次要结局
未报告次要终点