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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05013671
Enrollment
100
Registered
2021-08-19
Start date
2020-10-15
Completion date
2022-12-31
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPPV

Keywords

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

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.

Interventions

OTHERrepositioning 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

OTHERbalance

compare the balance of residents with BPPV with residents without BPPV

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
The presence of BPPVBaselineThis will be measured using the side lying test (posterior and anterior canal BPPV) and the side lying test for horizontal canal BPPV.
Dizziness Handicap InventoryBaselineSelf-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 InternationalBaselineMeasuring 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 balanceBaselineMeasuring 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)BaselineMeasuring dynamic balance and gait during TUG over a 3 meter distance
360° turnBaselineMeasuring dynamic balance during a 360° turn
10 meter walk testBaselineThe 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 strengthBaselineThe 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

MeasureTime frameDescription
Hospital anxiety and depression scale (HADS)BaselineThe 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.
Fall incidentsBaselineFalls incidents retrieved from nursing home staff
Frailty statusBaselineFrailty status using Fried Criteria
Katz-ADL (retrospective data retrieved from patient files)BaselineThe 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)BaselineMedication that may affect the vestibular system will be retrieved from patient files.
Sleep pattern (retrospective data retrieved from patient files)BaselineIf the participant has a normal/disturbed sleep pattern.
Comorbidities (retrospective data retrieved from patient files)BaselineThe number and kind of comorbidities including COVID-19 infection in the participants history.
Nutrition (retrospective data retrieved from patient files)BaselineIf 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)BaselineThe 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)BaselineThe 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.

Countries

Belgium

Contacts

Primary ContactJoke Spildooren, prof. dr.
joke.spildooren@uhasselt.be+32 11 26 91 78
Backup ContactLaura Casters, drs.
laura.casters@uhasselt.be+32 470 52 40 17

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026