Benign Paroxysmal Positional Vertigo in Older Adults

NCT05013684 | Unknown

• 1 other identifier: BPPVOA-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (12)

• the Montreal Cognitive Assessment (MOCA)

  Baseline

• the 15-item Geriatric Depression Scale

  baseline

• the 15-item Geriatric Depression Scale

  Month 1

• the 15-item Geriatric Depression Scale

  Month 3

• the 15-item Geriatric Depression Scale

  Month 6

Study Arms (2)

Older adults with BPPV

ACTIVE COMPARATOR

Other: Particle Repositioning Maneuver

Older adults without BPPV

NO INTERVENTION

Interventions

Particle Repositioning Maneuver OTHER

treatment with Particle Repositioning Maneuver

Older adults with BPPV

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joke Spildooren, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Sara Pauwels, drs.

  Hasselt University

  STUDY CHAIR

Central Study Contacts

Joke Spildooren, prof. dr.

CONTACT

+3211269178; joke.spildooren@uhasselt.be

Sara Pauwels, drs.

CONTACT

+32 11 26 88 55; sara.pauwels@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 19, 2021
• Study Start: July 8, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

BE (1)