Benign Paroxysmal Positional Vertigo in Older Adults: Treatment Efficacy and the Impact on Balance, Inactivity and Frailty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- The mini Balance Evalutation System test (miniBEStest)
研究概览
简要总结
Despite the growing research on Benign Paroxysmal Positioning Vertigo (BPPV), the impact and treatment efficacy on balance, physical activity (and consequently) frailty in elderly is lacking. Also, the added value of the video Head Impulse Test (vHIT) in this population has never been studied before. With insights gained from this research, we hope to contribute to an efficient treatment of BPPV in this growing population and to minimize its impact and healthcare burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons ≥ 65 years old
- •Able to stand independent for at least 30 seconds
- •Able to walk (with or without) walking aid for at least 10 meters
- •Patients diagnosed with posterior semicircular canal BPPV
- •Patients diagnosed with lateral-semicircular canal BPPV
排除标准
- •Unable to understand and follow simple instructions (e.g. due to severe dementia, hearing loss or visual impairment)
- •Persons temporarily or permanently living in a residential or psychiatric care centre, a home for the disabled or rehabilitation centre
- •Persons with contra-indications for the diagnostic maneuver, vHIT or caloric irrigation test (e.g. severe limitation in mobility of the cervical spine of perforation of the tympanic membrane)
- •Persons with other (acute) vestibular disorders and who as a result no longer meet the above mentioned diagnostic criteria for BPPV
- •Persons with evolutionary disorders of the central nervous system (e.g. multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis).
- •Persons who are already taking antivertigo drugs.
- •Persons still in the rehabilitation phase after an orthopedic or cardiovascular incident.
结局指标
主要结局
The mini Balance Evalutation System test (miniBEStest)
时间窗: month 6
The MiniBEStest is a 14-item test that measures 4 different balance control systems: anticipatory postural adjustments, reactive postural control, sensory orientation and dynamic gait. Items are scored on a 3-level ordinal scale. The CTSIB is used to assess sensory contributions to postural control during 6 sensory conditions: stand on firm surface with eyes open, stand on foam surface with eyes open, stand on firm surface with visual conflict dome, stand on foam surface with visual conflict dome, stand on firm surface with eyes closed and stand on foam surface with eyes closed.
10 meter walk test
时间窗: month 6
During the 10 meter walk test the participant is instructed to walk 10 meter at his/her preferred walking speed. Gait parameters will be assessed.
physical activity level measurde by an accelerometer (MOX)
时间窗: month 6
Objective measurement of physical activity level of four days will be done by an accelerometer (MOX), that measures time spent in certain positions. The accelerometer is attached to the upper leg of the participant.
The International Physical Activity Questionnaire
时间窗: Month 6
used to measure the level of physical activity by questionnaire. This questionnaire consists of 31 questions divided over 5 subcategories. A higher score means a higher level of physical activity.
Frailty
时间窗: month 6
Frailty is defined as a clinical syndrome in which three or more of the following criteria are present: unintentional weight loss (more than 3 kg during last year and/or BMI ≤ 21 kg/m2), weakness (unable to rise from a chair), self-reported exhaustion, slow walking speed (velocity on 10 meter walk test) and low physical activity (answering 'no' to the question 'do you perform regular physical activity as walking, gardening or sport).
次要结局
- the 15-item Geriatric Depression Scale(Month 6)
- medication use(Throug study completion, an average of 6 months)
- the Montreal Cognitive Assessment (MOCA)(Baseline)
- BPPV-symptomatology(Throug study completion, an average of 6 months)
- Age(Throug study completion, an average of 6 months)
- Height(Throug study completion, an average of 6 months)
- Living situation(Throug study completion, an average of 6 months)
- Walking aid(Throug study completion, an average of 6 months)
- Fall history(Up to the end of the study)
研究者
JSpildooren
Principal Investigator
Hasselt University