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临床试验/NCT05115851
NCT05115851已完成不适用

Short Term Effects 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
Balance Evaluation Systems Test

研究概览

简要总结

To compare the effect of anodal cerebellar Transcranial Direct Current Stimulation (tDCS) vs anodal cerebral tDCS 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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The interventions were performed by trained physical therapist and the data was collected by independent assessor. Therapists, assessors and participants were blinded to group allocation throughout the duration of the trial.

入排标准

年龄范围
60 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

Balance Evaluation Systems Test

时间窗: Day 3

Changes from the baseline, 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)

Changes from the base line, Berg balance scale

时间窗: Day 3

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: Day 3

Changes from the Baseline, 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.

次要结局

  • Johns Hopkins fall risk assessment Tool(Day 3)
  • Montreal cognitive Scale(Day 3)
  • Timed 25-Foot Walk test(Day 3)
  • tDCS Adverse Effects Questionnaire(Day 3)
  • Mini mental state examination (MMSE)(Day 3)
  • 6 min walk test: Distance (meters)(Day 3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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