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

Study Overview
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Brief Summary
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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.

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

Conditions
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BPPV

Intervention / Treatment
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* Other: repositioning maneuvers
* Other: balance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: First, the nursing home resident will be assessed for the presence of BPPV. Based on the presence of BPPV, two groups will be formed: BPPV-group and control group. The residents suffering from BPPV will undergo balance tests and will be treated for their BPPV (BPPV-group). The nursing home residents with BPPV will be matched to residents without the disease (case control design) and will also undergo balance tests. At 1,3,6 and 12 months the presence of balance problems will be followed up in both groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: residents with BPPV<br> | Other: repositioning maneuvers<br>* 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<br>Other: balance<br>* compare the balance of residents with BPPV with residents without BPPV<br>|
| Other: residents without BPPV<br> | Other: balance<br>* compare the balance of residents with BPPV with residents without BPPV<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Paroxysmal Positional Vertigo, vertigo, older adults, frailty, nursing home