Institutional Frail ElderlyNCT02905292
Inactivity, Balance Problems and Fall Risk in Institutionalized Frail Elderly
An observational study of Institutional Frail Elderly, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Institutional Frail Elderly
- What is being tested?
- evaluation and treatment maneuver for BPPV
- How many people
- 400 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2016to Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: institutionalized frail elderly
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Joke Spildooren, dr. contact
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Hasselt, 3500
Joke Spildooren, dr.
About this study
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?
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.
- Conditions
- Institutional Frail Elderly
- Being tested
- evaluation and treatment maneuver for BPPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluation and treatment maneuver for BPPVOther
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: baseline
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: month 1
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: month 2
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: month 3
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: month 4
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: month 5
outcome of the vestibular bedside testing
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
Measured: month 6
static and dynamic balance using the Mobility lab (APDM-sensors)
static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG
Measured: baseline
static and dynamic balance using the Mobility lab (APDM-sensors)
static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG
Measured: month 3
Four Test Balance Scale (4TBS)
Measured: baseline
Four Test Balance Scale (4TBS)
Measured: month 1
Four Test Balance Scale (4TBS)
Measured: month 2
Four Test Balance Scale (4TBS)
Measured: month 3
Four Test Balance Scale (4TBS)
Measured: month 4
Four Test Balance Scale (4TBS)
Measured: month 5
Four Test Balance Scale (4TBS)
Measured: month 6
Functional Ambulation categories (FAC)
Measured: baseline
Functional Ambulation categories (FAC)
Measured: month 1
Functional Ambulation categories (FAC)
Measured: month 2
Functional Ambulation categories (FAC)
Measured: month 3
Functional Ambulation categories (FAC)
Measured: month 4
Functional Ambulation categories (FAC)
Measured: month 5
Functional Ambulation categories (FAC)
Measured: month 6
Dizziness Handicap Inventory (DHI)
Measured: baseline
Dizziness Handicap Inventory (DHI)
Measured: month 3
Secondary outcomes (13)
Fall incidents
Measured: baseline
Fall incidents
Measured: month 1
Fall incidents
Measured: month 2
Fall incidents
Measured: month 3
Fall incidents
Measured: month 4
Fall incidents
Measured: month 5
Fall incidents
Measured: month 6
fear of falling
fear of falling: Falls Efficacy Scale
Measured: baseline
fear of falling
fear of falling: Falls Efficacy Scale
Measured: month 3
depression
depression: Geriatric depression scale
Measured: baseline
depression
depression: Geriatric depression scale
Measured: month 3
ambulatory activity level
ambulatory activity level: the StepWatch Activity Monitor (SAM)
Measured: baseline
ambulatory activity level
ambulatory activity level: the StepWatch Activity Monitor (SAM)
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJun 2017 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Institutional Frail ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JSpildooren, Hasselt University
- Investigators
- Joke spildooren, dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905292
- Sponsor's protocol ID
- BPPV-ELDERLY-001
- Status last verified
- Sep 2016
- First submitted
- 14 Sep 2016
- Last updated
- 19 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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?
- ClinicalTrials.gov ID
- NCT02905292
- Acronym / sponsor ID
- BPPV-ELDERLY-001
- Conditions
- Institutional Frail Elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- institutionalized frail elderly
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evaluation and treatment maneuver for BPPV | Other | – |
Primary outcome
outcome of the vestibular bedside testing
Time frame: baseline
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
outcome of the vestibular bedside testing
Time frame: month 1
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
outcome of the vestibular bedside testing
Time frame: month 2
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
outcome of the vestibular bedside testing
Time frame: month 3
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
outcome of the vestibular bedside testing
Time frame: month 4
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
outcome of the vestibular bedside testing
Time frame: month 5
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
outcome of the vestibular bedside testing
Time frame: month 6
outcome of the vestibular bedside testing (i.e. Dix-Hallpike-, side lying- or roll-test)
static and dynamic balance using the Mobility lab (APDM-sensors)
Time frame: baseline
static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG
static and dynamic balance using the Mobility lab (APDM-sensors)
Time frame: month 3
static and dynamic balance using the Mobility lab (APDM-sensors): iSway (COP sway area and velocity with and without vision), iTUG
Four Test Balance Scale (4TBS)
Time frame: baseline
Four Test Balance Scale (4TBS)
Time frame: month 1
Four Test Balance Scale (4TBS)
Time frame: month 2
Four Test Balance Scale (4TBS)
Time frame: month 3
Four Test Balance Scale (4TBS)
Time frame: month 4
Four Test Balance Scale (4TBS)
Time frame: month 5
Four Test Balance Scale (4TBS)
Time frame: month 6
Functional Ambulation categories (FAC)
Time frame: baseline
Functional Ambulation categories (FAC)
Time frame: month 1
Functional Ambulation categories (FAC)
Time frame: month 2
Functional Ambulation categories (FAC)
Time frame: month 3
Functional Ambulation categories (FAC)
Time frame: month 4
Functional Ambulation categories (FAC)
Time frame: month 5
Functional Ambulation categories (FAC)
Time frame: month 6
Dizziness Handicap Inventory (DHI)
Time frame: baseline
Dizziness Handicap Inventory (DHI)
Time frame: month 3
13 secondary outcomes
Fall incidents
Time frame: baseline
Fall incidents
Time frame: month 1
Fall incidents
Time frame: month 2
Fall incidents
Time frame: month 3
Fall incidents
Time frame: month 4
Fall incidents
Time frame: month 5
Fall incidents
Time frame: month 6
fear of falling
Time frame: baseline
fear of falling
Time frame: month 3
depression
Time frame: baseline
depression
Time frame: month 3
ambulatory activity level
Time frame: baseline
ambulatory activity level
Time frame: month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joke Spildooren, dr. contact
Joke spildooren, dr. principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Institutional Frail Elderly, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joke Spildooren, dr. (joke.spildooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome of the vestibular bedside testing (time frame: baseline). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2016.