Effect of Cervical Exercises in Addition to Vestibular Rehabilitation in the Treatment of Peripheral Vestibular Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks
研究概览
简要总结
70 patients with peripheral vestibular disorders will be included in the study. Half of the subjects will receive vestibular rehabilitation exercises and the other half will receive additional cervical exercises. Results from the two groups will be compared.
详细描述
70 patients with a diagnosis of peripheral vestibular disease will be enrolled in the study. Patient selection will be carried out in the physiatry, otorhinolaryngology and neurology outpatient clinics of our university hospital. Eligible patients will be informed about the study and those that accept to take part in the study will be referred to an investigator for history taking and physical examination. Demographic data, medical history and examination findings will be recorded. After initial assessment, all patients will receive a short education regarding vestibular exercises that they will be asked to do at home. A second investigator will be responsible for the randomization of subjects into two groups according to a computer generated randomization table and that same investigator will prescribe the second group additional cervical exercises to do in addition to the vestibular rehabilitation exercises.
After one months, patients will be reassessed and their measurements will be recorded. Statistical analyses will be carried out to compare the outcome scores of the two groups.
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 (Investigator, Outcomes Assessor)
盲法说明
Investigator responsible for clinical assessment will be blinded to subject's intervention group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of peripheral vestibular disease
- •Being older than 18 years of age
排除标准
- •Psychostimulant or psychotropic drug use that might alter vestibular functions
- •Severe neurological, psychiatric or orthopedic disorder that might alter patients' ability to comply with the exercise program.
结局指标
主要结局
Change from baseline The activities-specific balance confidence (ABC) scale at 4 weeks
时间窗: Baseline and 4th week visit
A questionnaire that measures an individual's confidence during ambulatory activities. The scale is scored from 0 to 100. 100 indicates better outcome.
Change from baseline Dizziness handicap inventory at 4 weeks
时间窗: Baseline and 4th week visit
A 25-item self-report questionnaire that quantifies the impact of dizziness on daily life by measuring self-perceived handicap. The scale is scored from 0 to 100. 100 indicates better outcome.
Change from baseline Gait speed at 4 weeks
时间窗: Baseline and 4th week visit
Gait speed is the time one takes to walk a specified distance on level surfaces over a short distance. Gait speed has different reference values according to age and sex.
Change from baseline Romberg test at 4 weeks
时间窗: Baseline and 4th week visit
A balance test that challenges the vestibular, proprioceptive and visual systems. Subject is asked to stand erect with eyes open/closed, on a hard/smooth surface and with feet side by side/ in tandem.Normally a person is expected to be able to stand in these positions for 30 seconds.
Change from baseline Dynamic gait index at 4 weeks
时间窗: Baseline and 4th week visit
An inventory that assesses individual's ability to modify balance while walking in the presence of external demands. Highest possible score is 24 points and lower scores indicate worse outcome.
Change from baseline Functional gait assessment at 4 weeks
时间窗: Baseline and 4th week visit
An index that is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. Highest score is 30 points and higher scores denote better outcome.
次要结局
- Change from baseline Visual analog scale for dizziness at 4 weeks(Baseline and 4th week visit)
- Change from baseline Visual analog scale for neck pain at 4 weeks(Baseline and 4th week visit)
研究者
Ece Cinar
Principal investigator
Ege University