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临床试验/NCT07206485
NCT07206485已完成不适用

Effect of Vibroacoustic Therapy Device With Laser Motion Guidance on Balance Sensory Integration in Patients With Stroke

October 6 University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Biodex balance system

研究概览

简要总结

PURPOSE: to investigate the effect of vibroacoustic therapy device with laser motion guidance affect balance sensory integration in patients with stroke BACKGROUND: Following stroke, motor recovery can be dictated by the degree of sensory disruption, The application of vibroacoustic therapy device with laser motion guidance could improve balance and sensory integration functions.

详细描述

Forty-four patients post vascular stroke, from both sexes were participated in this study. The patients were randomly divided into four equal groups; Group (I) will receive vibroacoustic therapy and a selected physical therapy program. Group (II) will receive laser motion guidance therapy and a selected physical therapy program. Group (III) will receive vibroacoustic therapy, laser motion guidance and a selected physical therapy program. Group (IV) will receive the selected physical therapy program. The evaluation methods by Biodex balance system using Clinical Test of Sensory Integration and Balance (CTSIB), Time up and go test, and The Functional Independence Measure

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
None

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Forty-four patients post vascular stroke, according to a sample size calculation
  • •Both genders (males and females) will participate in the study.
  • •The age of patients will be from 45 to 60 years.
  • •The duration of the stroke will be at least 6 months.

排除标准

  • •Other brain injuries/ illnesses, cognitive impairment, serious sensory impairment (superficial, deep, or cortical sensation) or proprioceptive loss, vestibular disorders
  • •Severe apraxia, severe aphasia
  • •contractures that restrict patients movement

研究组 & 干预措施

Group (I)

Experimental

will receive vibroacoustic therapy and a selected physical therapy program.

干预措施: vibro-acoustic therapy (Device)

Group (I)

Experimental

will receive vibroacoustic therapy and a selected physical therapy program.

干预措施: selected physical therapy exercises program (Other)

Group (II)

Experimental

laser motion guidance therapy and a selected physical therapy program

干预措施: Motion Guidance Laser (Device)

Group (II)

Experimental

laser motion guidance therapy and a selected physical therapy program

干预措施: selected physical therapy exercises program (Other)

Group (III)

Experimental

vibroacoustic therapy, laser motion guidance and a selected physical therapy program

干预措施: vibro-acoustic therapy (Device)

Group (III)

Experimental

vibroacoustic therapy, laser motion guidance and a selected physical therapy program

干预措施: Motion Guidance Laser (Device)

Group (III)

Experimental

vibroacoustic therapy, laser motion guidance and a selected physical therapy program

干预措施: selected physical therapy exercises program (Other)

Group (IV)

Experimental

the selected physical therapy program

干预措施: selected physical therapy exercises program (Other)

结局指标

主要结局

Biodex balance system

时间窗: four weeks

Clinical Test of Sensory Integration and Balance (CTSIB) The Biodex Balance System provides objective, computer-based measurements for the Clinical Test of Sensory Integration and Balance (CTSIB), also known as the Sensory Organization Test (SOT), by quantifying postural sway under various sensory conditions.

Time up and go test (TUG)

时间窗: four weeks

The TUG is a general physical performance test used to assess mobility, balance, and locomotor performance in elderly people

Biodex balance system Overall Stability Index (OSI)

时间窗: four weeks

The Biodex Overall Stability Index (OSI) is a composite measure of postural stability provided by the Biodex Balance System (BBS). It quantifies how well a person can maintain balance by measuring the total deviation of the foot platform from level in both anterior-posterior (front-to-back) and medial-lateral (side-to-side) directions

次要结局

  • The Functional Independence Measure (FIM) scale(four weeks)

研究者

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

Lama Saad El-Din Mahmoud

Assistant Professor of Neurology and Neurosurgery Faculty of Physical Therapy October 6 University

October 6 University

研究点 (1)

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