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临床试验/NCT03973255
NCT03973255已完成不适用

Efficacy Of Biofeedback Training And Whole Body Vibration Therapy In Vestibular Rehabilitation Of Unilateral Vestibular Weakness

Pamukkale University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年3月13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
90
试验地点
1
主要终点
vertigo visual analogue scale

研究概览

简要总结

The aim of this study was to compare the efficacy of home based vestibular rehabilitation program, posturographic biofeedback training and whole body vibration therapy on balance, fall risk, functional mobility, vertigo symptom severity and functions in patients with unilateral vestibular weakness.

详细描述

A total of 90 patients who were diagnosed as unilateral vestibular weakness were included in this prospective randomized controlled study. They were randomized into three groups each consisting of 30 patients. Home based vestibular rehabilitation program was given to all groups. Fall risk yielded by posturography, Berg balance scale, Timed Up-and-Go test, vertigo visual analogue scale and Dizziness Handicap Inventory were used for comparison.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients who had unilateral vestibular weakness and persistent dizziness at least two months after acute period were included Bithermal caloric test showing hyporesponsiveness higher than 30% or unresponsiveness of the horizontal canal of the affected ear accepted as unilateral vestibular weakness.

排除标准

  • •Bilateral vestibular weakness, Recurrent vestibulopathy, Benign paroxysmal positional vertigo, Concomitant neurological or psychiatric disease, Severe visual or auditory impairments and orthopedic problems in the lower extremities

研究组 & 干预措施

Home based vestibular rehabilitation program

Placebo Comparator

Home-based vestibular rehabilitation program including vestibular adaptation exercises, oculomotor exercises, static and dynamic balance exercises was given to each group in the form of a booklet. All exercises were demonstrated and performed first time at hospital under supervision. Booklet with descriptions and pictures of each exercise were given to patients in order to enable them to perform exercises at home. Vestibular rehabilitation exercises were prescribed as once daily with 10 repetitions at home for one month and wanted to mark a chart if the exercises were performed daily. A diary was used to monitor adherence with the program.

干预措施: Rehabilitation (Behavioral)

Biofeedback training

Active Comparator

Biofeedback training was performed five days a week during a month for 20 minutes for a total of 20 sessions with Tetrax ® (Sunlight Medical Ltd) static posture analysis device. Biofeedback training including "catch, speedball, sky ball, gotcha" exercises which requires following a visual target during weight transfer movements, capturing fast-moving objects by changing the center of gravity or quickly escaping from incoming objects, were applied to the patients in biofeedback training. There is a 30 seconds pause between each exercise.

干预措施: Rehabilitation (Behavioral)

Whole body vibration

Active Comparator

Whole body vibration training was also performed five days a week during a month for 20 minutes for a total of 20 sessions with Power Plate Pro 5 (MDD CE 0086). In whole body vibration, single leg, squat and deep squat positions were applied respectively with 35 Hz frequency, including rest periods of 30 seconds between each application.

干预措施: Rehabilitation (Behavioral)

结局指标

主要结局

vertigo visual analogue scale

时间窗: 30 days

A vertically oriented 10 cm line was used for VAS, where "no vertigo" corresponds to the bottom of the line and "the worst vertigo that they could imagine" corresponds to the top of the line. Patients were instructed to place a mark on the 10-cm vertical line according to severity of their vertigo.

Dizziness Handicap Inventory

时间窗: 30 days

The DHI has 25 items, sub-grouped into three domains: functional, emotional, and physical. There are three closed-form answers where patients may check one of the following: yes, sometimes and no with the corresponding scored as 4/2/0. It is possible to use both the total score and the scores of the three subscales separately.

fall risk

时间窗: 30 days

fall risk yielded by static posturography

Timed Up-and-Go

时间窗: 30 days

TUG is a balance and gait index which requires subjects to rise from an armchair, walk 3 m at a normal and safe pace, turn around, walk back to the chair and sit-down. The time required to complete this task is measured in seconds.

Berg balance scale

时间窗: 30 days

BBS consists of 14 tasks that are each scored on a scale of 0-4, for a total possible score of 56, indicating no identified balance difficulties. Scoring is on a 5-point ordinal scale with 0 indicating an inability to complete the task and 4 as independent in completing the task.

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

Fazıl Necdet Ardıç

Prof.Dr.Fazıl Necdet Ardıç

Pamukkale University

研究点 (1)

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