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

Sponsor
Hasselt University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05013671
Collaborator
(none)
100
1
2
26.5
3.8

Study Details

Study Description

Brief 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). 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.

Condition or Disease Intervention/Treatment Phase
  • Other: repositioning maneuvers
  • Other: balance
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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)
Primary Purpose:
Other
Official Title:
Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
Actual Study Start Date :
Oct 15, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. The presence of BPPV [Baseline]

    This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.

  2. The presence of BPPV [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.

  3. The presence of BPPV [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.

  4. The presence of BPPV [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.

  5. The presence of BPPV [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.

  6. Dizziness Handicap Inventory [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.

  7. Dizziness Handicap Inventory [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.

  8. Dizziness Handicap Inventory [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.

  9. Dizziness Handicap Inventory [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.

  10. Dizziness Handicap Inventory [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.

  11. Falls Efficacy Scale International [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).

  12. Falls Efficacy Scale International [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).

  13. Falls Efficacy Scale International [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).

  14. Falls Efficacy Scale International [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).

  15. Falls Efficacy Scale International [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).

  16. Static balance [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.

  17. Static balance [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.

  18. Static balance [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.

  19. Static balance [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.

  20. Static balance [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.

  21. Timed up and Go (TUG) [Baseline]

    Measuring dynamic balance and gait during TUG over a 3 meter distance

  22. Timed up and Go (TUG) [Month 1]

    Measuring dynamic balance and gait during TUG over a 3 meter distance

  23. Timed up and Go (TUG) [Month 3]

    Measuring dynamic balance and gait during TUG over a 3 meter distance

  24. Timed up and Go (TUG) [Month 6]

    Measuring dynamic balance and gait during TUG over a 3 meter distance

  25. Timed up and Go (TUG) [Month 12]

    Measuring dynamic balance and gait during TUG over a 3 meter distance

  26. 360° turn [Baseline]

    Measuring dynamic balance during a 360° turn

  27. 360° turn [month 1]

    Measuring dynamic balance during a 360° turn

  28. 360° turn [month 3]

    Measuring dynamic balance during a 360° turn

  29. 360° turn [month 6]

    Measuring dynamic balance during a 360° turn

  30. 360° turn [month 12]

    Measuring dynamic balance during a 360° turn

  31. 10 meter walk test [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.

  32. 10 meter walk test [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.

  33. 10 meter walk test [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.

  34. 10 meter walk test [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.

  35. 10 meter walk test [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.

  36. Knee extensor strength [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.

  37. Knee extensor strength [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.

  38. Knee extensor strength [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.

  39. Knee extensor strength [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.

  40. Knee extensor strength [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.

Secondary Outcome Measures

  1. Fall incidents [Baseline]

    Falls incidents retrieved from nursing home staff

  2. Fall incidents [month 1]

    Falls incidents retrieved from nursing home staff

  3. Fall incidents [month 3]

    Falls incidents retrieved from nursing home staff

  4. Fall incidents [month 6]

    Falls incidents retrieved from nursing home staff

  5. Fall incidents [month 12]

    Falls incidents retrieved from nursing home staff

  6. Katz-ADL (retrospective data retrieved from patient files) [Baseline]

    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.

  7. Katz-ADL (retrospective data retrieved from patient files) [Month 1]

    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.

  8. Katz-ADL (retrospective data retrieved from patient files) [Month 3]

    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.

  9. Katz-ADL (retrospective data retrieved from patient files) [Month 6]

    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.

  10. Katz-ADL (retrospective data retrieved from patient files) [Month 12]

    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.

  11. Medication (retrospective data retrieved from patient files) [Baseline]

    Medication that may affect the vestibular system will be retrieved from patient files.

  12. Medication (retrospective data retrieved from patient files) [Month 1]

    Medication that may affect the vestibular system will be retrieved from patient files.

  13. Medication (retrospective data retrieved from patient files) [Month 3]

    Medication that may affect the vestibular system will be retrieved from patient files.

  14. Medication (retrospective data retrieved from patient files) [Month 6]

    Medication that may affect the vestibular system will be retrieved from patient files.

  15. Medication (retrospective data retrieved from patient files) [Month 12]

    Medication that may affect the vestibular system will be retrieved from patient files.

  16. Sleep pattern (retrospective data retrieved from patient files) [Baseline]

    If the participant has a normal/disturbed sleep pattern.

  17. Sleep pattern (retrospective data retrieved from patient files) [Month 1]

    If the participant has a normal/disturbed sleep pattern.

  18. Sleep pattern (retrospective data retrieved from patient files) [Month 3]

    If the participant has a normal/disturbed sleep pattern.

  19. Sleep pattern (retrospective data retrieved from patient files) [Month 6]

    If the participant has a normal/disturbed sleep pattern.

  20. Sleep pattern (retrospective data retrieved from patient files) [Month 12]

    If the participant has a normal/disturbed sleep pattern.

  21. Comorbidities (retrospective data retrieved from patient files) [Baseline]

    The number and kind of comorbidities including COVID-19 infection in the participants history.

  22. Comorbidities (retrospective data retrieved from patient files) [Month 1]

    The number and kind of comorbidities including COVID-19 infection in the participants history.

  23. Comorbidities (retrospective data retrieved from patient files) [Month 3]

    The number and kind of comorbidities including COVID-19 infection in the participants history.

  24. Comorbidities (retrospective data retrieved from patient files) [Month 6]

    The number and kind of comorbidities including COVID-19 infection in the participants history.

  25. Comorbidities (retrospective data retrieved from patient files) [Month 12]

    The number and kind of comorbidities including COVID-19 infection in the participants history.

  26. Nutrition (retrospective data retrieved from patient files) [Baseline]

    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.

  27. Nutrition (retrospective data retrieved from patient files) [Month 1]

    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.

  28. Nutrition (retrospective data retrieved from patient files) [Month 3]

    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.

  29. Nutrition (retrospective data retrieved from patient files) [Month 6]

    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

  30. Nutrition (retrospective data retrieved from patient files) [Month 12]

    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.

  31. Geriatric Depression Scale (GDS) [Baseline]

    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".

  32. Geriatric Depression Scale (GDS) [Month 1]

    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".

  33. Geriatric Depression Scale (GDS) [Month 3]

    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".

  34. Geriatric Depression Scale (GDS) [Month 6]

    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".

  35. Geriatric Depression Scale (GDS) [Month 12]

    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".

  36. Montreal Cognitive Assessment (MOCA) [Baseline]

    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.

  37. Montreal Cognitive Assessment (MOCA) [Month 1]

    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.

  38. Montreal Cognitive Assessment (MOCA) [Month 3]

    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.

  39. Montreal Cognitive Assessment (MOCA) [Month 6]

    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.

  40. Montreal Cognitive Assessment (MOCA) [Month 12]

    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.

  41. Hospital anxiety and depression scale (HADS) [Baseline]

    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.

  42. Hospital anxiety and depression scale (HADS) [Month 1]

    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.

  43. Hospital anxiety and depression scale (HADS) [Month 3]

    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.

  44. Hospital anxiety and depression scale (HADS) [Month 6]

    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.

  45. Hospital anxiety and depression scale (HADS) [Month 12]

    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.

  46. Frailty status [Baseline]

    Frailty status using Fried Criteria

  47. Frailty status [month 1]

    Frailty status using Fried Criteria

  48. Frailty status [month 3]

    Frailty status using Fried Criteria

  49. Frailty status [month 6]

    Frailty status using Fried Criteria

  50. Frailty status [month 12]

    Frailty status using Fried Criteria

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 WZC Leopoldspark Leopoldsburg Belgium 3970

Sponsors and Collaborators

  • Hasselt University

Investigators

  • Principal Investigator: Joke Spildooren, prof. dr., Hasselt University
  • Study Chair: Laura Casters, drs., Hasselt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
JSpildooren, Principal Investigator, Hasselt University
ClinicalTrials.gov Identifier:
NCT05013671
Other Study ID Numbers:
  • BPPV in WCZ - 001
First Posted:
Aug 19, 2021
Last Update Posted:
Aug 19, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by JSpildooren, Principal Investigator, Hasselt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 19, 2021