Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls

BPPV is a benign condition of the balance organ, localized in the inner ear, in which calcium crystals loosen up and move freely in the endolymphatic fluid of the inner ear (more specifically in the semi-circular canals). During certain posture changes or head movements, these moving calcium crystals cause dizziness and balance problems. The general objective of the study is to evaluate the impact of BPPV on the balance of older adults in nursing homes. For this purpose, we will compare the balance of residents with BPPV with residents without BPPV. Furthermore, we will identify the impact of treatment on balance problems and fall risk in older adults in nursing homes.

Study Overview

• Status: Recruiting
• Conditions: BPPV
• Intervention / Treatment: Other: repositioning maneuvers; Other: balance

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joke Spildooren, prof. dr.; Phone Number: +32 11 26 91 78; Email: joke.spildooren@uhasselt.be
• Study Contact Backup: Name: Laura Casters, drs.; Phone Number: +32 470 52 40 17; Email: laura.casters@uhasselt.be

Study Locations

• Belgium
  • Leopoldsburg, Belgium, 3970
    • Recruiting
    • WZC Leopoldspark
    • Contact: Laura Casters, drs.; Phone Number: +32 470 52 40 17; Email: laura.casters@uhasselt.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Institutionalized for at least 3 months
• Willing to participate
• Able to understand simple instructions
• Able to stand independently for 10 seconds (with the use of a walking aid)

Exclusion Criteria:

• Diagnosis of progressive neurological conditions resulting in a fast deterioration (i.e. amyotrophic lateral sclerosis or residents with palliative care)
• Participation in a rehabilitation program at the current time for a pathology of less than 6 months
• Contra-indication for vestibular testing such as heart failure or fear

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: residents with BPPV	Other: repositioning maneuvers; The calcium crystals floating in the endolymphatic fluid will put back in place by putting the patient in several sitting and lying positions during specific repositioning maneuvers. During these maneuvers the calcium crystals will float from the semicircular canals back into the utriculus, after which the dizziness symptoms should disappear; Other: balance; compare the balance of residents with BPPV with residents without BPPV
Other: residents without BPPV	Other: balance; compare the balance of residents with BPPV with residents without BPPV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The presence of BPPV	This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.	Baseline
The presence of BPPV	This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.	Month 1
The presence of BPPV	This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.	Month 3
The presence of BPPV	This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.	Month 6
The presence of BPPV	This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.	Month 12
Dizziness Handicap Inventory	Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.	Baseline
Dizziness Handicap Inventory	Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.	Month 1
Dizziness Handicap Inventory	Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.	Month 3
Dizziness Handicap Inventory	Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.	Month 6
Dizziness Handicap Inventory	Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.	Month 12
Falls Efficacy Scale International	Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).	Baseline
Falls Efficacy Scale International	Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).	Month 1
Falls Efficacy Scale International	Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).	Month 3
Falls Efficacy Scale International	Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).	Month 6
Falls Efficacy Scale International	Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).	Month 12
Static balance	Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.	Baseline
Static balance	Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.	Month 1
Static balance	Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.	Month 3
Static balance	Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.	Month 6
Static balance	Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.	Month 12
Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Baseline
Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 1
Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 3
Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 6
Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 12
360° turn	Measuring dynamic balance during a 360° turn	Baseline
360° turn	Measuring dynamic balance during a 360° turn	month 1
360° turn	Measuring dynamic balance during a 360° turn	month 3
360° turn	Measuring dynamic balance during a 360° turn	month 6
360° turn	Measuring dynamic balance during a 360° turn	month 12
10 meter walk test	The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.	Baseline
10 meter walk test	The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.	Month 1
10 meter walk test	The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.	Month 3
10 meter walk test	The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.	Month 6
10 meter walk test	The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.	Month 12
Knee extensor strength	The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.	Baseline
Knee extensor strength	The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.	Month 1
Knee extensor strength	The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.	Month 3
Knee extensor strength	The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.	Month 6
Knee extensor strength	The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fall incidents	Falls incidents retrieved from nursing home staff	Baseline
Fall incidents	Falls incidents retrieved from nursing home staff	month 1
Fall incidents	Falls incidents retrieved from nursing home staff	month 3
Fall incidents	Falls incidents retrieved from nursing home staff	month 6
Fall incidents	Falls incidents retrieved from nursing home staff	month 12
Katz-ADL (retrospective data retrieved from patient files)	The Katz-scale assesses functional status as a measurement of the client's ability to perform activities of daily living independently. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.	Baseline
Katz-ADL (retrospective data retrieved from patient files)	The Katz-scale assesses functional status as a measurement of the client's ability to perform activities of daily living independently. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.	Month 1
Katz-ADL (retrospective data retrieved from patient files)	The Katz-scale assesses functional status as a measurement of the client's ability to perform activities of daily living independently. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.	Month 3
Katz-ADL (retrospective data retrieved from patient files)	The Katz-scale assesses functional status as a measurement of the client's ability to perform activities of daily living independently. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.	Month 6
Katz-ADL (retrospective data retrieved from patient files)	The Katz-scale assesses functional status as a measurement of the client's ability to perform activities of daily living independently. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.	Month 12
Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Baseline
Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 1
Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 3
Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 6
Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 12
Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Baseline
Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 1
Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 3
Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 6
Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 12
Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Baseline
Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 1
Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 3
Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 6
Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 12
Nutrition (retrospective data retrieved from patient files)	If the participant is on a specific diet (i.e.salt-free diet, low fat diet, calcium-rich diet etc.) and if there is a loss of apetite.	Baseline
Nutrition (retrospective data retrieved from patient files)	If the participant is on a specific diet (i.e.salt-free diet, low fat diet, calcium-rich diet etc.) and if there is a loss of apetite.	Month 1
Nutrition (retrospective data retrieved from patient files)	If the participant is on a specific diet (i.e.salt-free diet, low fat diet, calcium-rich diet etc.) and if there is a loss of apetite.	Month 3
Nutrition (retrospective data retrieved from patient files)	If the participant is on a specific diet (i.e.salt-free diet, low fat diet, calcium-rich diet etc.) and if there is a loss of apetite	Month 6
Nutrition (retrospective data retrieved from patient files)	If the participant is on a specific diet (i.e.salt-free diet, low fat diet, calcium-rich diet etc.) and if there is a loss of apetite.	Month 12
Geriatric Depression Scale (GDS)	The GDS is commonly used as a routine part of a Comprehensive Geriatric Assessment. One point is assigned to each answer and the cumulative score is rated on a scoring grid.[2] The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	Baseline
Geriatric Depression Scale (GDS)	The GDS is commonly used as a routine part of a Comprehensive Geriatric Assessment. One point is assigned to each answer and the cumulative score is rated on a scoring grid.[2] The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	Month 1
Geriatric Depression Scale (GDS)	The GDS is commonly used as a routine part of a Comprehensive Geriatric Assessment. One point is assigned to each answer and the cumulative score is rated on a scoring grid.[2] The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	Month 3
Geriatric Depression Scale (GDS)	The GDS is commonly used as a routine part of a Comprehensive Geriatric Assessment. One point is assigned to each answer and the cumulative score is rated on a scoring grid.[2] The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	Month 6
Geriatric Depression Scale (GDS)	The GDS is commonly used as a routine part of a Comprehensive Geriatric Assessment. One point is assigned to each answer and the cumulative score is rated on a scoring grid.[2] The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	Month 12
Montreal Cognitive Assessment (MOCA)	The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia.	Baseline
Montreal Cognitive Assessment (MOCA)	The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia.	Month 1
Montreal Cognitive Assessment (MOCA)	The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia.	Month 3
Montreal Cognitive Assessment (MOCA)	The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia.	Month 6
Montreal Cognitive Assessment (MOCA)	The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia.	Month 12
Hospital anxiety and depression scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. Only the questions related to the anxiety subscale will be used. The total score ranges from 0 to 21, a score >8 denotes anxiety.	Baseline
Hospital anxiety and depression scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. Only the questions related to the anxiety subscale will be used. The total score ranges from 0 to 21, a score >8 denotes anxiety.	Month 1
Hospital anxiety and depression scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. Only the questions related to the anxiety subscale will be used. The total score ranges from 0 to 21, a score >8 denotes anxiety.	Month 3
Hospital anxiety and depression scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. Only the questions related to the anxiety subscale will be used. The total score ranges from 0 to 21, a score >8 denotes anxiety.	Month 6
Hospital anxiety and depression scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients. Only the questions related to the anxiety subscale will be used. The total score ranges from 0 to 21, a score >8 denotes anxiety.	Month 12
Frailty status	Frailty status using Fried Criteria	Baseline
Frailty status	Frailty status using Fried Criteria	month 1
Frailty status	Frailty status using Fried Criteria	month 3
Frailty status	Frailty status using Fried Criteria	month 6
Frailty status	Frailty status using Fried Criteria	month 12

Collaborators and Investigators

• Sponsor: Hasselt University
• Investigators: Study Chair: Laura Casters, drs., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: older adults; frailty; Benign Paroxysmal Positional Vertigo; vertigo; nursing home
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: BPPV in WCZ - 001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No