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

BPPV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05013671
• Other study ID #: BPPV in WCZ - 001
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Hasselt University
• Contact: Joke Spildooren, prof. dr.
• Phone: +32 11 26 91 78
• Email: joke.spildooren[@]uhasselt.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• BPPV
• Dizziness
• Vertigo

Intervention

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
• balance
compare the balance of residents with BPPV with residents without BPPV

Locations

Country	Name	City	State
Belgium	WZC Leopoldspark	Leopoldsburg

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Baseline
Primary	Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 1
Primary	Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 3
Primary	Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 6
Primary	Timed up and Go (TUG)	Measuring dynamic balance and gait during TUG over a 3 meter distance	Month 12
Primary	360° turn	Measuring dynamic balance during a 360° turn	Baseline
Primary	360° turn	Measuring dynamic balance during a 360° turn	month 1
Primary	360° turn	Measuring dynamic balance during a 360° turn	month 3
Primary	360° turn	Measuring dynamic balance during a 360° turn	month 6
Primary	360° turn	Measuring dynamic balance during a 360° turn	month 12
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Fall incidents	Falls incidents retrieved from nursing home staff	Baseline
Secondary	Fall incidents	Falls incidents retrieved from nursing home staff	month 1
Secondary	Fall incidents	Falls incidents retrieved from nursing home staff	month 3
Secondary	Fall incidents	Falls incidents retrieved from nursing home staff	month 6
Secondary	Fall incidents	Falls incidents retrieved from nursing home staff	month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Baseline
Secondary	Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 1
Secondary	Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 3
Secondary	Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 6
Secondary	Medication (retrospective data retrieved from patient files)	Medication that may affect the vestibular system will be retrieved from patient files.	Month 12
Secondary	Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Baseline
Secondary	Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 1
Secondary	Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 3
Secondary	Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 6
Secondary	Sleep pattern (retrospective data retrieved from patient files)	If the participant has a normal/disturbed sleep pattern.	Month 12
Secondary	Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Baseline
Secondary	Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 1
Secondary	Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 3
Secondary	Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 6
Secondary	Comorbidities (retrospective data retrieved from patient files)	The number and kind of comorbidities including COVID-19 infection in the participants history.	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frailty status	Frailty status using Fried Criteria	Baseline
Secondary	Frailty status	Frailty status using Fried Criteria	month 1
Secondary	Frailty status	Frailty status using Fried Criteria	month 3
Secondary	Frailty status	Frailty status using Fried Criteria	month 6
Secondary	Frailty status	Frailty status using Fried Criteria	month 12