Benign Paroxysmal Positional Vertigo in Older Adults
Primary Purpose
Benign Paroxysmal Positional Vertigo
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Particle Repositioning Maneuver
Sponsored by
About this trial
This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo
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.
Sites / Locations
- Ziekenhuis Oost-LimburgRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Older adults with BPPV
Older adults without BPPV
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
Secondary Outcome Measures
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.
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
the 15-item Geriatric Depression Scale
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Age
Years
Height
meters
BPPV-symptomatology
medication use
medication use will be questioned
Living situation
Living situation wil be questioned
Walking aid
Walking aid wil be questioned
Fall history
Fall History will be measured during the follow-up period by a 2-weekly telephone interview.
Full Information
NCT ID
NCT05013684
First Posted
August 16, 2021
Last Updated
August 18, 2021
Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
1. Study Identification
Unique Protocol Identification Number
NCT05013684
Brief Title
Benign Paroxysmal Positional Vertigo in Older Adults
Official Title
Benign Paroxysmal Positional Vertigo in Older Adults: Treatment Efficacy and the Impact on Balance, Inactivity and Frailty
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Older adults with BPPV
Arm Type
Active Comparator
Arm Title
Older adults without BPPV
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Particle Repositioning Maneuver
Intervention Description
treatment with Particle Repositioning Maneuver
Primary Outcome Measure Information:
Title
The mini Balance Evalutation System test (miniBEStest)
Description
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.
Time Frame
baseline
Title
The mini Balance Evalutation System test (miniBEStest)
Description
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.
Time Frame
month 1
Title
The mini Balance Evalutation System test (miniBEStest)
Description
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.
Time Frame
month 3
Title
The mini Balance Evalutation System test (miniBEStest)
Description
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.
Time Frame
month 6
Title
10 meter walk test
Description
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.
Time Frame
Baseline
Title
10 meter walk test
Description
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.
Time Frame
month 1
Title
10 meter walk test
Description
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.
Time Frame
month 3
Title
10 meter walk test
Description
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.
Time Frame
month 6
Title
physical activity level measurde by an accelerometer (MOX)
Description
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.
Time Frame
baseline
Title
physical activity level measurde by an accelerometer (MOX)
Description
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.
Time Frame
month 1
Title
physical activity level measurde by an accelerometer (MOX)
Description
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.
Time Frame
month 3
Title
physical activity level measurde by an accelerometer (MOX)
Description
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.
Time Frame
month 6
Title
The International Physical Activity Questionnaire
Description
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.
Time Frame
Baseline
Title
The International Physical Activity Questionnaire
Description
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.
Time Frame
Month 1
Title
The International Physical Activity Questionnaire
Description
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.
Time Frame
Month 3
Title
The International Physical Activity Questionnaire
Description
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.
Time Frame
Month 6
Title
Frailty
Description
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).
Time Frame
baseline
Title
Frailty
Description
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).
Time Frame
month 1
Title
Frailty
Description
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).
Time Frame
month 3
Title
Frailty
Description
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).
Time Frame
month 6
Secondary Outcome Measure Information:
Title
the Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Baseline
Title
the 15-item Geriatric Depression Scale
Description
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Time Frame
baseline
Title
the 15-item Geriatric Depression Scale
Description
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Time Frame
Month 1
Title
the 15-item Geriatric Depression Scale
Description
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Time Frame
Month 3
Title
the 15-item Geriatric Depression Scale
Description
Depressive feeling will be measured with the 15-item Geriatric Depression Scale
Time Frame
Month 6
Title
Age
Description
Years
Time Frame
Throug study completion, an average of 6 months
Title
Height
Description
meters
Time Frame
Throug study completion, an average of 6 months
Title
BPPV-symptomatology
Time Frame
Throug study completion, an average of 6 months
Title
medication use
Description
medication use will be questioned
Time Frame
Throug study completion, an average of 6 months
Title
Living situation
Description
Living situation wil be questioned
Time Frame
Throug study completion, an average of 6 months
Title
Walking aid
Description
Walking aid wil be questioned
Time Frame
Throug study completion, an average of 6 months
Title
Fall history
Description
Fall History will be measured during the follow-up period by a 2-weekly telephone interview.
Time Frame
Up to the end of the study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joke Spildooren, prof. dr.
Phone
+3211269178
Email
joke.spildooren@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Pauwels, drs.
Phone
+32 11 26 88 55
Email
sara.pauwels@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joke Spildooren, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Pauwels, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nele Lemkens, MD
Phone
+32 11 26 88 55
Email
Nele.lemkens@zol.be
First Name & Middle Initial & Last Name & Degree
Sara Pauwels, drs
Phone
+32 11 26 88 55
Email
sara.pauwels@uhasselt.be
12. IPD Sharing Statement
Learn more about this trial
Benign Paroxysmal Positional Vertigo in Older Adults
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