Reducing Rate of Falls in Older People With the Improvement of Balance by Means of Vestibular Rehabilitation: Preliminary Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 主要终点
- CDP average
研究概览
简要总结
The aim of this study is to evaluate the effectiveness of vestibular rehabilitation to improve the balance in older people and reduce the number of falls, comparing three arms with different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group.
详细描述
Vestibular rehabilitation has been shown to be effective in compensating patients with residual instability as a result of vestibular system disorders or Parkinson's disease. It is also useful for treating lack of balance in the elderly (presbivertigo). However, there is no systematic, controlled and prospective analysis of whether vestibular rehabilitation is effective in reducing the number of falls in the elderly, or whether its effects in this age group are temporary or persist over time.
This study compare vestibular rehabilitation with three different strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group, in people over 65 years. Balance tests are performed before vestibular rehabilitation and three weeks, six months and one year after it. Number of falls are quantified one year after vestibular rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Double (Investigator, Outcomes Assessor)
After the first screening visit, the patients who grant their consent will be included in the study and randomised to one of the following study arms. Randomisation will be performed by C.H.U de Santiago Clinical Epidemiology and Biostatistics Unit. Once the informed consent form is signed, the care provider will contact the unit, which will give him the code of the arm to which the patient is assigned. A n= 20 block balanced randomisation sequence will be used. The investigator will analyse results and evolution, being blind type and duration of vestibular rehabilitation.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with a high risk of falling shall meet at least one of the following requirements:
- •Having fallen at least once in the last 12 months.
- •Using more than 15 seconds or needing support in the TUG test (normal limit calculated in previous studies).
- •Obtaining a mean CDP SOT balance score of < 68% (normal limit calculated in previous studies).
- •Having fallen at least once in the CDP SOT.
排除标准
- •Cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises.
- •Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises.
- •Balance disorders caused by conditions other than age (neurologic, vestibular...).
- •Reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.
研究组 & 干预措施
Vestibular rehabil.: CDP
Group A. The Smart Equitest program was used with a protocol of 10 exercises per session, which were customized depending on each patient´s deficit. The exercises involve visual biofeedback together with sensitive, real-time monitoring of movement. In some exercises, patients must maintain their center of gravity (COG) over the base of support, while in others the COG must be moved to a series of targets. In addition, the support surface and/or visual surround may also move in response to the patient´s own movement. The exercise difficulty was progressively increased throughout the rehabilitation sessions. The duration of each session was approximately 15 minutes. The distribution of sessions was one per day and five per week (2 weeks).
干预措施: Vestibular rehabil.: CDP (Device)
Vestibular rehabil.: optokinetic stimuli
Group B. Patient has to stand in a dark room, wiht optokinetic stimuli around him/her. Ten sessions (one per day, five per week, two weeks), with progressive increase of stimulus speed (from 30º/sec the first day to 100º/sec the last), duration of session (from 5 minutes the first day to 15 minutes the last), stimulus complexity (horizontal stimuli in the first sessions, progressively adding vertical and rotating stimuli) and support surface difficulty (initially hard surface, last sessions on foam).
干预措施: Vestibular rehabil.: optokinetic stimuli (Device)
Vestibular rehabil.: home exercises
Group C. The patient is given a list of exercises (and explained how to do them) to stabilise eye position and improve postural control. They are to be performed twice a day for two weeks. Approximate duration of each session: 15 minutes. The exercises must be supervised by a family member to verify adherence to the programme.
干预措施: Vestibular rehabil.: home exercises (Other)
Control group
Group D. No vestibular rehabilitation is developed.
结局指标
主要结局
CDP average
时间窗: 12 months
Average score in the Sensory Organization Test of the Computerized Dynamic Posturography
次要结局
- Falls(12 months)
- Short FES-I score(12 months)
- Hospitalisations(12 months)
- Timed-up-and-go steps(12 months)
- DHI score(12 months)
- Timed-up-and-go time(12 months)
研究者
Andrés Soto-Varela
Professor and Attending Physician
Hospital Clinico Universitario de Santiago