Benign Paroxysmal Positional Vertigo in Older Adults

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Benign Paroxysmal Positional Vertigo in Older Adults: Treatment Efficacy and the Impact on Balance, Inactivity and Frailty

Conditions
-----------------
Benign Paroxysmal Positional Vertigo

Intervention / Treatment
-----------------
* Other: Particle Repositioning Maneuver


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Older adults with BPPV<br> | Other: Particle Repositioning Maneuver<br>* treatment with Particle Repositioning Maneuver<br>|
| No Intervention: Older adults without BPPV<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mini Balance Evalutation System test (miniBEStest) | 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. | baseline | 
| The mini Balance Evalutation System test (miniBEStest) | 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. | month 1 | 
| The mini Balance Evalutation System test (miniBEStest) | 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. | month 3 | 
| The mini Balance Evalutation System test (miniBEStest) | 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. | month 6 | 
| 10 meter walk test | 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. | Baseline | 
| 10 meter walk test | 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. | month 1 | 
| 10 meter walk test | 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. | month 3 | 
| 10 meter walk test | 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. | month 6 | 
| physical activity level measurde by an accelerometer (MOX) | 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. | baseline | 
| physical activity level measurde by an accelerometer (MOX) | 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. | month 1 | 
| physical activity level measurde by an accelerometer (MOX) | 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. | month 3 | 
| physical activity level measurde by an accelerometer (MOX) | 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. | month 6 | 
| The International Physical Activity Questionnaire | 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. | Baseline | 
| The International Physical Activity Questionnaire | 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. | Month 1 | 
| The International Physical Activity Questionnaire | 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. | Month 3 | 
| The International Physical Activity Questionnaire | 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. | Month 6 | 
| Frailty | 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). | baseline | 
| Frailty | 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). | month 1 | 
| Frailty | 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). | month 3 | 
| Frailty | 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). | month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Montreal Cognitive Assessment (MOCA) | Cognitive function of older adults with BPPV will be compared to cognitive function of older adults without BPPV. Cognitive function will be assessed with the Montreal Cognitive Assessment (MOCA). MOCA assesses short term memory, visuospatial abilities, executive functions, attention and working memory, language and orientation to time and place. | Baseline | 
| the 15-item Geriatric Depression Scale | Depressive feeling will be measured with the 15-item Geriatric Depression Scale | baseline | 
| the 15-item Geriatric Depression Scale | Depressive feeling will be measured with the 15-item Geriatric Depression Scale | Month 1 | 
| the 15-item Geriatric Depression Scale | Depressive feeling will be measured with the 15-item Geriatric Depression Scale | Month 3 | 
| the 15-item Geriatric Depression Scale | Depressive feeling will be measured with the 15-item Geriatric Depression Scale | Month 6 | 
| Age | Years | Throug study completion, an average of 6 months | 
| Height | meters | Throug study completion, an average of 6 months | 
| BPPV-symptomatology |  | Throug study completion, an average of 6 months | 
| medication use | medication use will be questioned | Throug study completion, an average of 6 months | 
| Living situation | Living situation wil be questioned | Throug study completion, an average of 6 months | 
| Walking aid | Walking aid wil be questioned | Throug study completion, an average of 6 months | 
| Fall history | Fall History will be measured during the follow-up period by a 2-weekly telephone interview. | Up to the end of the study |