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

Primary Purpose

BPPV

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
repositioning maneuvers
balance
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for BPPV focused on measuring Benign Paroxysmal Positional Vertigo, vertigo, older adults, frailty, nursing home

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • WZC LeopoldsparkRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

residents with BPPV

residents without BPPV

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
Timed up and Go (TUG)
Measuring dynamic balance and gait during TUG over a 3 meter distance
360° turn
Measuring dynamic balance during a 360° turn
360° turn
Measuring dynamic balance during a 360° turn
360° turn
Measuring dynamic balance during a 360° turn
360° turn
Measuring dynamic balance during a 360° turn
360° turn
Measuring dynamic balance during a 360° turn
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Fall incidents
Falls incidents retrieved from nursing home staff
Fall incidents
Falls incidents retrieved from nursing home staff
Fall incidents
Falls incidents retrieved from nursing home staff
Fall incidents
Falls incidents retrieved from nursing home staff
Fall incidents
Falls incidents retrieved from nursing home staff
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.
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.
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.
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.
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.
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Medication (retrospective data retrieved from patient files)
Medication that may affect the vestibular system will be retrieved from patient files.
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Sleep pattern (retrospective data retrieved from patient files)
If the participant has a normal/disturbed sleep pattern.
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
Comorbidities (retrospective data retrieved from patient files)
The number and kind of comorbidities including COVID-19 infection in the participants history.
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.
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.
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.
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
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.
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".
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".
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".
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".
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".
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Frailty status
Frailty status using Fried Criteria
Frailty status
Frailty status using Fried Criteria
Frailty status
Frailty status using Fried Criteria
Frailty status
Frailty status using Fried Criteria
Frailty status
Frailty status using Fried Criteria

Full Information

First Posted
September 17, 2020
Last Updated
August 18, 2021
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT05013671
Brief Title
Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
Official Title
Benign Paroxysmal Positional Vertigo (BPPV) in Nursing Homes: Treatment Efficacy and Impact on Balance, Gait and Falls
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BPPV
Keywords
Benign Paroxysmal Positional Vertigo, vertigo, older adults, frailty, nursing home

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
residents with BPPV
Arm Type
Active Comparator
Arm Title
residents without BPPV
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
repositioning maneuvers
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
balance
Intervention Description
compare the balance of residents with BPPV with residents without BPPV
Primary Outcome Measure Information:
Title
The presence of BPPV
Description
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Time Frame
Baseline
Title
The presence of BPPV
Description
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Time Frame
Month 1
Title
The presence of BPPV
Description
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Time Frame
Month 3
Title
The presence of BPPV
Description
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Time Frame
Month 6
Title
The presence of BPPV
Description
This will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Time Frame
Month 12
Title
Dizziness Handicap Inventory
Description
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.
Time Frame
Baseline
Title
Dizziness Handicap Inventory
Description
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.
Time Frame
Month 1
Title
Dizziness Handicap Inventory
Description
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.
Time Frame
Month 3
Title
Dizziness Handicap Inventory
Description
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.
Time Frame
Month 6
Title
Dizziness Handicap Inventory
Description
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.
Time Frame
Month 12
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Baseline
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Month 1
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Month 3
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Month 6
Title
Falls Efficacy Scale International
Description
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).
Time Frame
Month 12
Title
Static balance
Description
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.
Time Frame
Baseline
Title
Static balance
Description
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.
Time Frame
Month 1
Title
Static balance
Description
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.
Time Frame
Month 3
Title
Static balance
Description
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.
Time Frame
Month 6
Title
Static balance
Description
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.
Time Frame
Month 12
Title
Timed up and Go (TUG)
Description
Measuring dynamic balance and gait during TUG over a 3 meter distance
Time Frame
Baseline
Title
Timed up and Go (TUG)
Description
Measuring dynamic balance and gait during TUG over a 3 meter distance
Time Frame
Month 1
Title
Timed up and Go (TUG)
Description
Measuring dynamic balance and gait during TUG over a 3 meter distance
Time Frame
Month 3
Title
Timed up and Go (TUG)
Description
Measuring dynamic balance and gait during TUG over a 3 meter distance
Time Frame
Month 6
Title
Timed up and Go (TUG)
Description
Measuring dynamic balance and gait during TUG over a 3 meter distance
Time Frame
Month 12
Title
360° turn
Description
Measuring dynamic balance during a 360° turn
Time Frame
Baseline
Title
360° turn
Description
Measuring dynamic balance during a 360° turn
Time Frame
month 1
Title
360° turn
Description
Measuring dynamic balance during a 360° turn
Time Frame
month 3
Title
360° turn
Description
Measuring dynamic balance during a 360° turn
Time Frame
month 6
Title
360° turn
Description
Measuring dynamic balance during a 360° turn
Time Frame
month 12
Title
10 meter walk test
Description
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.
Time Frame
Baseline
Title
10 meter walk test
Description
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.
Time Frame
Month 1
Title
10 meter walk test
Description
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.
Time Frame
Month 3
Title
10 meter walk test
Description
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.
Time Frame
Month 6
Title
10 meter walk test
Description
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.
Time Frame
Month 12
Title
Knee extensor strength
Description
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.
Time Frame
Baseline
Title
Knee extensor strength
Description
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.
Time Frame
Month 1
Title
Knee extensor strength
Description
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.
Time Frame
Month 3
Title
Knee extensor strength
Description
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.
Time Frame
Month 6
Title
Knee extensor strength
Description
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.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Fall incidents
Description
Falls incidents retrieved from nursing home staff
Time Frame
Baseline
Title
Fall incidents
Description
Falls incidents retrieved from nursing home staff
Time Frame
month 1
Title
Fall incidents
Description
Falls incidents retrieved from nursing home staff
Time Frame
month 3
Title
Fall incidents
Description
Falls incidents retrieved from nursing home staff
Time Frame
month 6
Title
Fall incidents
Description
Falls incidents retrieved from nursing home staff
Time Frame
month 12
Title
Katz-ADL (retrospective data retrieved from patient files)
Description
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.
Time Frame
Baseline
Title
Katz-ADL (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 1
Title
Katz-ADL (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 3
Title
Katz-ADL (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 6
Title
Katz-ADL (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 12
Title
Medication (retrospective data retrieved from patient files)
Description
Medication that may affect the vestibular system will be retrieved from patient files.
Time Frame
Baseline
Title
Medication (retrospective data retrieved from patient files)
Description
Medication that may affect the vestibular system will be retrieved from patient files.
Time Frame
Month 1
Title
Medication (retrospective data retrieved from patient files)
Description
Medication that may affect the vestibular system will be retrieved from patient files.
Time Frame
Month 3
Title
Medication (retrospective data retrieved from patient files)
Description
Medication that may affect the vestibular system will be retrieved from patient files.
Time Frame
Month 6
Title
Medication (retrospective data retrieved from patient files)
Description
Medication that may affect the vestibular system will be retrieved from patient files.
Time Frame
Month 12
Title
Sleep pattern (retrospective data retrieved from patient files)
Description
If the participant has a normal/disturbed sleep pattern.
Time Frame
Baseline
Title
Sleep pattern (retrospective data retrieved from patient files)
Description
If the participant has a normal/disturbed sleep pattern.
Time Frame
Month 1
Title
Sleep pattern (retrospective data retrieved from patient files)
Description
If the participant has a normal/disturbed sleep pattern.
Time Frame
Month 3
Title
Sleep pattern (retrospective data retrieved from patient files)
Description
If the participant has a normal/disturbed sleep pattern.
Time Frame
Month 6
Title
Sleep pattern (retrospective data retrieved from patient files)
Description
If the participant has a normal/disturbed sleep pattern.
Time Frame
Month 12
Title
Comorbidities (retrospective data retrieved from patient files)
Description
The number and kind of comorbidities including COVID-19 infection in the participants history.
Time Frame
Baseline
Title
Comorbidities (retrospective data retrieved from patient files)
Description
The number and kind of comorbidities including COVID-19 infection in the participants history.
Time Frame
Month 1
Title
Comorbidities (retrospective data retrieved from patient files)
Description
The number and kind of comorbidities including COVID-19 infection in the participants history.
Time Frame
Month 3
Title
Comorbidities (retrospective data retrieved from patient files)
Description
The number and kind of comorbidities including COVID-19 infection in the participants history.
Time Frame
Month 6
Title
Comorbidities (retrospective data retrieved from patient files)
Description
The number and kind of comorbidities including COVID-19 infection in the participants history.
Time Frame
Month 12
Title
Nutrition (retrospective data retrieved from patient files)
Description
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.
Time Frame
Baseline
Title
Nutrition (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 1
Title
Nutrition (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 3
Title
Nutrition (retrospective data retrieved from patient files)
Description
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
Time Frame
Month 6
Title
Nutrition (retrospective data retrieved from patient files)
Description
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.
Time Frame
Month 12
Title
Geriatric Depression Scale (GDS)
Description
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".
Time Frame
Baseline
Title
Geriatric Depression Scale (GDS)
Description
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".
Time Frame
Month 1
Title
Geriatric Depression Scale (GDS)
Description
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".
Time Frame
Month 3
Title
Geriatric Depression Scale (GDS)
Description
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".
Time Frame
Month 6
Title
Geriatric Depression Scale (GDS)
Description
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".
Time Frame
Month 12
Title
Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Baseline
Title
Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Month 1
Title
Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Month 3
Title
Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Month 6
Title
Montreal Cognitive Assessment (MOCA)
Description
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.
Time Frame
Month 12
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
Baseline
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
Month 1
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
Month 3
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
Month 6
Title
Hospital anxiety and depression scale (HADS)
Description
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.
Time Frame
Month 12
Title
Frailty status
Description
Frailty status using Fried Criteria
Time Frame
Baseline
Title
Frailty status
Description
Frailty status using Fried Criteria
Time Frame
month 1
Title
Frailty status
Description
Frailty status using Fried Criteria
Time Frame
month 3
Title
Frailty status
Description
Frailty status using Fried Criteria
Time Frame
month 6
Title
Frailty status
Description
Frailty status using Fried Criteria
Time Frame
month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joke Spildooren, prof. dr.
Phone
+32 11 26 91 78
Email
joke.spildooren@uhasselt.be
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Casters, drs.
Phone
+32 470 52 40 17
Email
laura.casters@uhasselt.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joke Spildooren, prof. dr.
Organizational Affiliation
Hasselt University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Casters, drs.
Organizational Affiliation
Hasselt University
Official's Role
Study Chair
Facility Information:
Facility Name
WZC Leopoldspark
City
Leopoldsburg
ZIP/Postal Code
3970
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Casters, drs.
Phone
+32 470 52 40 17
Email
laura.casters@uhasselt.be

12. IPD Sharing Statement

Learn more about this trial

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

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