Clinical trial NCT02905292: Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly
Official title: Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly: What is the Impact of Benign Paroxysmal Positional Vertigo (BPPV) and Treatment Effectiveness?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Institutional Frail Elderly
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2016-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: institutionalized frail elderly

Brief summary: The overall objective of the research is to identify the prevalence and incidence of BPPV and the impact on balance problems, fall risk and inactivity in frail elderly. The investigators will demonstrate the importance of early diagnosis and treatment in this patient group.


Eligibility criteria: Inclusion Criteria:

* Institutionalized in a nursing home for at least 3 months
* Able to understand and follow simple instructions
* Able to stand independently for 30 seconds
* Willing to participate in the study

Exclusion Criteria:

* diagnosis of progressive neurological diseases (such as Amyotrophic Lateral Sclerosis) resulting in a fast decline within 3 months
* Rehabilitating for a neurological or orthopaedic incident such as knee prosthesis, stroke,... )
* Contra-indication for Hallpike and Epley maneuver

Primary outcomes:
measure: outcome of the vestibular bedside testing
timeFrame: baseline
measure: outcome of the vestibular bedside testing
timeFrame: month 1
measure: outcome of the vestibular bedside testing
timeFrame: month 2
measure: outcome of the vestibular bedside testing
timeFrame: month 3
measure: outcome of the vestibular bedside testing
timeFrame: month 4
measure: outcome of the vestibular bedside testing
timeFrame: month 5
measure: outcome of the vestibular bedside testing
timeFrame: month 6
measure: static and dynamic balance using the Mobility lab (APDM-sensors)
timeFrame: baseline
measure: static and dynamic balance using the Mobility lab (APDM-sensors)
timeFrame: month 3
measure: Four Test Balance Scale (4TBS)
timeFrame: baseline
measure: Four Test Balance Scale (4TBS)
timeFrame: month 1
measure: Four Test Balance Scale (4TBS)
timeFrame: month 2
measure: Four Test Balance Scale (4TBS)
timeFrame: month 3
measure: Four Test Balance Scale (4TBS)
timeFrame: month 4
measure: Four Test Balance Scale (4TBS)
timeFrame: month 5
measure: Four Test Balance Scale (4TBS)
timeFrame: month 6
measure: Functional Ambulation categories (FAC)
timeFrame: baseline
measure: Functional Ambulation categories (FAC)
timeFrame: month 1
measure: Functional Ambulation categories (FAC)
timeFrame: month 2
measure: Functional Ambulation categories (FAC)
timeFrame: month 3
measure: Functional Ambulation categories (FAC)
timeFrame: month 4
measure: Functional Ambulation categories (FAC)
timeFrame: month 5
measure: Functional Ambulation categories (FAC)
timeFrame: month 6
measure: Dizziness Handicap Inventory (DHI)
timeFrame: baseline
measure: Dizziness Handicap Inventory (DHI)
timeFrame: month 3
Secondary outcomes:
measure: Fall incidents
timeFrame: baseline
measure: Fall incidents
timeFrame: month 1
measure: Fall incidents
timeFrame: month 2
measure: Fall incidents
timeFrame: month 3
measure: Fall incidents
timeFrame: month 4
measure: Fall incidents
timeFrame: month 5
measure: Fall incidents
timeFrame: month 6
measure: fear of falling
timeFrame: baseline
measure: fear of falling
timeFrame: month 3
measure: depression
timeFrame: baseline
measure: depression
timeFrame: month 3
measure: ambulatory activity level
timeFrame: baseline
measure: ambulatory activity level
timeFrame: month 3
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
Study officials:
affiliation: Hasselt University
name: Joke spildooren, dr.
role: PRINCIPAL_INVESTIGATOR
References: