BPPVNCT05013671
Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
A study testing repositioning maneuvers and balance in people with BPPV, run by Hasselt University at 1 site in Belgium.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- BPPV
- What is being tested?
- repositioning maneuvers and balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
WZC Leopoldspark
Leopoldsburg, 3970
Laura Casters, drs., +32 470 52 40 17, laura.casters@uhasselt.be
About this study
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.
- Conditions
- BPPV
- Being tested
- repositioning maneuvers, balance
- Keywords
- Benign Paroxysmal Positional Vertigo, vertigo, older adults, frailty, nursing home
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repositioning maneuversOther
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
balanceOther
compare the balance of residents with BPPV with residents without BPPV
| Study group | Role | What they receive |
|---|---|---|
| residents with BPPV | Active comparator | Not described Receives: Other: repositioning maneuvers; Other: balance |
| residents without BPPV | Other | Not described Receives: Other: balance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Measured: Baseline
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Measured: Month 1
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Measured: Month 3
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Measured: Month 6
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Measured: Month 12
360° turn
Measuring dynamic balance during a 360° turn
Measured: Baseline
360° turn
Measuring dynamic balance during a 360° turn
Measured: month 1
360° turn
Measuring dynamic balance during a 360° turn
Measured: month 3
360° turn
Measuring dynamic balance during a 360° turn
Measured: month 6
360° turn
Measuring dynamic balance during a 360° turn
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Secondary outcomes (50)
Fall incidents
Falls incidents retrieved from nursing home staff
Measured: Baseline
Fall incidents
Falls incidents retrieved from nursing home staff
Measured: month 1
Fall incidents
Falls incidents retrieved from nursing home staff
Measured: month 3
Fall incidents
Falls incidents retrieved from nursing home staff
Measured: month 6
Fall incidents
Falls incidents retrieved from nursing home staff
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Measured: Baseline
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Measured: Month 1
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Measured: Month 3
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Measured: Month 6
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Measured: Month 12
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Measured: Baseline
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Measured: Month 1
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Measured: Month 3
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Measured: Month 6
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Measured: Month 12
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Measured: Baseline
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Measured: Month 1
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Measured: Month 3
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Measured: Month 6
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Frailty status
Frailty status using Fried Criteria
Measured: Baseline
Frailty status
Frailty status using Fried Criteria
Measured: month 1
Frailty status
Frailty status using Fried Criteria
Measured: month 3
Frailty status
Frailty status using Fried Criteria
Measured: month 6
Frailty status
Frailty status using Fried Criteria
Measured: month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start15 Oct 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPPVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JSpildooren, Hasselt University
- Investigators
- Joke Spildooren, prof. dr., Principal investigator, Hasselt UniversityLaura Casters, drs., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013671
- Sponsor's protocol ID
- BPPV in WCZ - 001
- Status last verified
- Aug 2021
- First submitted
- 17 Sep 2020
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
- ClinicalTrials.gov ID
- NCT05013671
- Acronym / sponsor ID
- BPPV in WCZ - 001
- Conditions
- BPPV
- Keywords
- Benign Paroxysmal Positional Vertigo, vertigo, older adults, frailty, nursing home
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| residents with BPPV | Active comparator | Other: repositioning maneuvers, Other: balance |
| residents without BPPV | Other | Other: balance |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| repositioning maneuversThe 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 | residents with BPPV |
| balancecompare the balance of residents with BPPV with residents without BPPV | Other | residents with BPPV, residents without BPPV |
Primary outcome
The presence of BPPV
Time frame: Baseline
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
The presence of BPPV
Time frame: Month 1
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
The presence of BPPV
Time frame: Month 3
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
The presence of BPPV
Time frame: Month 6
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
The presence of BPPV
Time frame: Month 12
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Dizziness Handicap Inventory
Time frame: Baseline
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.
Dizziness Handicap Inventory
Time frame: Month 1
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.
Dizziness Handicap Inventory
Time frame: Month 3
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.
Dizziness Handicap Inventory
Time frame: Month 6
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.
Dizziness Handicap Inventory
Time frame: Month 12
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.
Falls Efficacy Scale International
Time frame: Baseline
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).
Falls Efficacy Scale International
Time frame: Month 1
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).
Falls Efficacy Scale International
Time frame: Month 3
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).
Falls Efficacy Scale International
Time frame: Month 6
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).
Falls Efficacy Scale International
Time frame: Month 12
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).
Static balance
Time frame: Baseline
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.
Static balance
Time frame: Month 1
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.
Static balance
Time frame: Month 3
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.
Static balance
Time frame: Month 6
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.
Static balance
Time frame: Month 12
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.
Timed up and Go (TUG)
Time frame: Baseline
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Time frame: Month 1
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Time frame: Month 3
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Time frame: Month 6
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Time frame: Month 12
Measuring dynamic balance and gait during TUG over a 3 meter distance
360° turn
Time frame: Baseline
Measuring dynamic balance during a 360° turn
360° turn
Time frame: month 1
Measuring dynamic balance during a 360° turn
360° turn
Time frame: month 3
Measuring dynamic balance during a 360° turn
360° turn
Time frame: month 6
Measuring dynamic balance during a 360° turn
360° turn
Time frame: month 12
Measuring dynamic balance during a 360° turn
10 meter walk test
Time frame: Baseline
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.
10 meter walk test
Time frame: Month 1
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.
10 meter walk test
Time frame: Month 3
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.
10 meter walk test
Time frame: Month 6
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.
10 meter walk test
Time frame: Month 12
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.
Knee extensor strength
Time frame: Baseline
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.
Knee extensor strength
Time frame: Month 1
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.
Knee extensor strength
Time frame: Month 3
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.
Knee extensor strength
Time frame: Month 6
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.
Knee extensor strength
Time frame: Month 12
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.
50 secondary outcomes
Fall incidents
Time frame: Baseline
Fall incidents
Time frame: month 1
Fall incidents
Time frame: month 3
Fall incidents
Time frame: month 6
Fall incidents
Time frame: month 12
Katz-ADL (retrospective data retrieved from patient files)
Time frame: Baseline
Katz-ADL (retrospective data retrieved from patient files)
Time frame: Month 1
Katz-ADL (retrospective data retrieved from patient files)
Time frame: Month 3
Katz-ADL (retrospective data retrieved from patient files)
Time frame: Month 6
Katz-ADL (retrospective data retrieved from patient files)
Time frame: Month 12
Medication (retrospective data retrieved from patient files)
Time frame: Baseline
Medication (retrospective data retrieved from patient files)
Time frame: Month 1
Medication (retrospective data retrieved from patient files)
Time frame: Month 3
Medication (retrospective data retrieved from patient files)
Time frame: Month 6
Medication (retrospective data retrieved from patient files)
Time frame: Month 12
Sleep pattern (retrospective data retrieved from patient files)
Time frame: Baseline
Sleep pattern (retrospective data retrieved from patient files)
Time frame: Month 1
Sleep pattern (retrospective data retrieved from patient files)
Time frame: Month 3
Sleep pattern (retrospective data retrieved from patient files)
Time frame: Month 6
Sleep pattern (retrospective data retrieved from patient files)
Time frame: Month 12
Comorbidities (retrospective data retrieved from patient files)
Time frame: Baseline
Comorbidities (retrospective data retrieved from patient files)
Time frame: Month 1
Comorbidities (retrospective data retrieved from patient files)
Time frame: Month 3
Comorbidities (retrospective data retrieved from patient files)
Time frame: Month 6
Comorbidities (retrospective data retrieved from patient files)
Time frame: Month 12
Nutrition (retrospective data retrieved from patient files)
Time frame: Baseline
Nutrition (retrospective data retrieved from patient files)
Time frame: Month 1
Nutrition (retrospective data retrieved from patient files)
Time frame: Month 3
Nutrition (retrospective data retrieved from patient files)
Time frame: Month 6
Nutrition (retrospective data retrieved from patient files)
Time frame: Month 12
Geriatric Depression Scale (GDS)
Time frame: Baseline
Geriatric Depression Scale (GDS)
Time frame: Month 1
Geriatric Depression Scale (GDS)
Time frame: Month 3
Geriatric Depression Scale (GDS)
Time frame: Month 6
Geriatric Depression Scale (GDS)
Time frame: Month 12
Montreal Cognitive Assessment (MOCA)
Time frame: Baseline
Montreal Cognitive Assessment (MOCA)
Time frame: Month 1
Montreal Cognitive Assessment (MOCA)
Time frame: Month 3
Montreal Cognitive Assessment (MOCA)
Time frame: Month 6
Montreal Cognitive Assessment (MOCA)
Time frame: Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Related trials for BPPV
Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke Spildooren, prof. dr. principal investigator
Hasselt University
Laura Casters, drs. study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing repositioning maneuvers and balance in people with BPPV, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joke Spildooren, prof. dr. (+32 11 26 91 78, joke.spildooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of BPPV (time frame: Baseline). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2021.