Benign Paroxysmal Positional Vertigo in Older Adults

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05013684
• Other study ID #: BPPVOA-001
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: Joke Spildooren, prof. dr.
• Phone: +3211269178
• Email: joke.spildooren[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

Other:
• Particle Repositioning Maneuver
treatment with Particle Repositioning Maneuver

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Ziekenhuis Oost-Limburg

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	baseline
Secondary	the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	Month 1
Secondary	the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	Month 3
Secondary	the 15-item Geriatric Depression Scale	Depressive feeling will be measured with the 15-item Geriatric Depression Scale	Month 6
Secondary	Age	Years	Throug study completion, an average of 6 months
Secondary	Height	meters	Throug study completion, an average of 6 months
Secondary	BPPV-symptomatology		Throug study completion, an average of 6 months
Secondary	medication use	medication use will be questioned	Throug study completion, an average of 6 months
Secondary	Living situation	Living situation wil be questioned	Throug study completion, an average of 6 months
Secondary	Walking aid	Walking aid wil be questioned	Throug study completion, an average of 6 months
Secondary	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