跳至主要内容
临床试验/NCT06882213
NCT06882213Enrolling By Invitation不适用

Unlocking Trunk Potential After Stroke: A Novel Approach Combining Transcranial Direct Current Stimulation and Core Stability Exercise

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
1
主要终点
Trunk Impairment Scale (TIS).

研究概览

简要总结

To evaluate the effects of the combining transcranial direct current stimulation with core stability exercises on trunk performance in poststroke hemiparetic patients, the secondary outcome is to evaluate the balance and the functional performance of the participants.

详细描述

This study will conduct to 60 male and female patients with post stroke hemiparesis with age ranged between 55 to 70 years, the patients will be categorized to two equal groups.

  • Group A (study group): will receive simultaneously a combination of transcranial direct current stimulation combined with core stability exercise.
  • Group B (control group): will receive core stability exercise. All patients will be assessed for trunk performance, balance, and functional performance before and after interventions.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients will be included if they are ≥ 55 years old of both sex, had a first-time right or left stroke within the preceding six months that damaged the cerebral cortex verified by (computed tomography or MRI report, neurological examination, and medical chart).
  • •Patients can stand and walk independently.
  • •Modified Ashworth Scale (MAS) of upper limb muscle ≤ 1+.
  • •All the patients received a conventional physiotherapy program in the acute stage and post-discharge from the hospital.
  • •None of the patients participated in any other study or placebo

排除标准

  • •Patients with neurological or orthopedic problems, paralysis neglect, behavioral abnormalities, dementia any shoulder dysfunction before or post-stroke (dislocation or subluxation), or those who using upper limb splints.
  • •Recurrent strokes or hemiparesis due to other neurological causes rather than stroke eg .(Brain tumor).
  • •Obesity (BMI ≥ 30 kg/m2).

研究组 & 干预措施

Control group

Active Comparator

will receive core stability exercise.

干预措施: core stability exercise. (Other)

Study Group

Active Comparator

will receive simultaneously a combination of transcranial direct current stimulation combined with core stability exercise.

干预措施: transcranial direct current stimulation (Other)

Study Group

Active Comparator

will receive simultaneously a combination of transcranial direct current stimulation combined with core stability exercise.

干预措施: core stability exercise. (Other)

结局指标

主要结局

Trunk Impairment Scale (TIS).

时间窗: up to 8 weeks

trunk performance will be assessed by Trunk Impairment Scale (TIS).

Berg Balance Scale

时间窗: up to 8 weeks

Balance will be assessed by berg balance scale, the balance score ranges from 0 to 56, with lower scores indicating increased risk of balance loss and higher scores indicating improved functional mobility. Time up and go test (TUG)n Score \< 10 seconds = normal \< 20 seconds = good mobility; can walk outside alone; does not require a walking aid \< 30 seconds = walking and balance problems; cannot walk outside alone; requires walking aid

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Youssef Elhamrawy

Lecturer of Physical therapy

Beni-Suef University

研究点 (1)

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