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

NCT05013671 | Unknown

• 1 other identifier: BPPV in WCZ - 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

BPPV

Keywords

Benign Paroxysmal Positional Vertigo; vertigo; older adults; frailty; nursing home

Outcome Measures

Primary Outcomes (40)

• The presence of BPPV

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

  Baseline

• The presence of BPPV

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

  Month 1

• The presence of BPPV

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

  Month 3

• The presence of BPPV

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

  Month 6

• The presence of BPPV

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

  Month 12

• Dizziness Handicap Inventory

  Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.

  Baseline

• Dizziness Handicap Inventory

  Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.

  Month 1

• Dizziness Handicap Inventory

  Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.

  Month 3

• Dizziness Handicap Inventory

  Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.

  Month 6

• Dizziness Handicap Inventory

  Self-reported impact of dizziness on daily life. There is a maximum score of 100 (28 points for physical, 36 points for emotional and 36 points for functional) and a minimum score of 0. The higher score, the greater the perceived handicap due to dizziness.

  Month 12

• Falls Efficacy Scale International

  Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).

  Baseline

• Falls Efficacy Scale International

  Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).

  Month 1

• Falls Efficacy Scale International

  Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).

  Month 3

• Falls Efficacy Scale International

  Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).

  Month 6

• Falls Efficacy Scale International

  Measuring fear of falling during daily and social activities. There is a minimum score of 16 (no concern about falling) to maximum 64 (severe concern about falling).

  Month 12

• Static balance

  Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.

  Baseline

• Static balance

  Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.

  Month 1

• Static balance

  Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.

  Month 3

• Static balance

  Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.

  Month 6

• Static balance

  Measuring balance in four positions: stand straight with eyes open (firm surface), standing straight with eyes closed (firm surface), standing straight on a foam with eyes open and standing straight on a foam with eyes closed.

  Month 12

• Timed up and Go (TUG)

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

  Baseline

• Timed up and Go (TUG)

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

  Month 1

• Timed up and Go (TUG)

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

  Month 3

• Timed up and Go (TUG)

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

  Month 6

• Timed up and Go (TUG)

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

  Month 12

• 360° turn

  Measuring dynamic balance during a 360° turn

  Baseline

• 360° turn

  Measuring dynamic balance during a 360° turn

  month 1

• 360° turn

  Measuring dynamic balance during a 360° turn

  month 3

• 360° turn

  Measuring dynamic balance during a 360° turn

  month 6

• 360° turn

  Measuring dynamic balance during a 360° turn

  month 12

• 10 meter walk test

  The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.

  Baseline

• 10 meter walk test

  The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.

  Month 1

• 10 meter walk test

  The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.

  Month 3

• 10 meter walk test

  The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.

  Month 6

• 10 meter walk test

  The participant walks 10 meters at a comfortable pace. A walking aid/orthosis can be used during the test, but the help from a third party during is prohibited. Body movements will be registered wuth the use of ADPM sensors.

  Month 12

• Knee extensor strength

  The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.

  Baseline

• Knee extensor strength

  The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.

  Month 1

• Knee extensor strength

  The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.

  Month 3

• Knee extensor strength

  The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.

  Month 6

• Knee extensor strength

  The strength of the knee extensor muscles of the right leg will be assessed with hand-held dynamometry (MicroFET). This dynamometer is placed between the leg segment to be evaluated and the examiner's hand. Participants were asked to sit with their legs over the end of a standard, examination table, with hips and knees flexed to 90. Participants have to hold the side-edges of the table with their hands and carry out a maximal isometric voluntary contraction for 3-5 s. The break method will be used to asses the knee extensor strength. This test will be performed 3 times.

  Month 12

Secondary Outcomes (50)

• Fall incidents

  Baseline

• Fall incidents

  month 1

• Fall incidents

  month 3

• Fall incidents

  month 6

• Fall incidents

  month 12

Study Arms (2)

residents with BPPV

ACTIVE COMPARATOR

Other: repositioning maneuvers; Other: balance

residents without BPPV

OTHER

Other: balance

Interventions

repositioning maneuvers OTHER

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

residents with BPPV

balance OTHER

compare the balance of residents with BPPV with residents without BPPV

residents with BPPV; residents without BPPV

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

WZC Leopoldspark

Leopoldsburg, 3970, Belgium

RECRUITING

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo; Frailty

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Joke Spildooren, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Laura Casters, drs.

  Hasselt University

  STUDY CHAIR

Central Study Contacts

Joke Spildooren, prof. dr.

CONTACT

+32 11 26 91 78; joke.spildooren@uhasselt.be

Laura Casters, drs.

CONTACT

+32 470 52 40 17; laura.casters@uhasselt.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: August 19, 2021
• Study Start: October 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

BE (1)