跳至主要内容
临床试验/NCT05129683
NCT05129683已完成不适用

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

Riphah International University2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2021年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
2
主要终点
Changes from the base line, Berg balance scale

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Changes from the base line, Berg balance scale

时间窗: Immediately after Intervention and then again after 1 hour.

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

时间窗: Immediately after Intervention and then again after 1 hour.

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

时间窗: Immediately after Intervention and then again after 1 hour.

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)

次要结局

  • tDCS Adverse Effects Questionnaire :(Immediately after Intervention and then again after 1 hour.)
  • Montreal cognitive Scale(1 hour)
  • Mini mental state examination (MMSE)(Immediately after Intervention and then again after 1 hour.)
  • 6 min walk test: Distance (meters)(Immediately after Intervention and then again after 1 hour.)
  • Timed 25-Foot Walk test(Immediately after Intervention and then again after 1 hour.)
  • Johns Hopkins fall risk assessment Tool(Immediately after Intervention and then again after 1 hour.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验