Postural ImbalancePhase 2NCT02655796
A Device for Screening of Fall Risk in the Elderly
A Phase 2 study testing OAK in people with Postural Imbalance and Gait, Unsteady, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the Centers for Disease Control and Prevention (CDC). The OAK device is a technologic system, based on virtual reality. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Imbalance, Gait, Unsteady
- What is being tested?
- OAK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2015to May 2017
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to walk without walking aids.
- Signed informed consent.
Who cannot join
- Neurological, musculoskeletal and orthopaedic disorders limiting mobility function and equilibrium. Psychiatric disorders. Any other medical condition limiting mobility function, as diabetes, obesity, serious ocular disorders (e.g. glaucoma), vestibular disorders (e.g. labyrinthitis) and proprioceptive disorders (e.g. ataxia).
- Pacemaker.
- Surgical interventions for orthopaedic disorders (e.g. knee or hip prosthesis) during the previous 6 months.
- Drug intake altering coordination and equilibrium (e.g. anti-epileptic, sedative-hypnotic drugs).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design
This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the Centers for Disease Control and Prevention (CDC).
The OAK device is a technologic system, based on virtual reality. It allows to quickly perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact with the OAK device through simple exercises, then the device provides an assessment of their functional mobility, equilibrium and postural reactions.
Read the detailed description
Falls are a serious problem among the elderly. Most falls do not cause death, but 20%-30% of falls result in serious injuries representing a significant source of morbidity and mortality. Good evidence shows that many falls can be prevented. Thus, identifying people with risk of falling is crucial. The aim of this study is the evaluation of the screening accuracy of a device (OAK) in assessing fall risk in the elderly.
Participants are recruited at IRCCS Galeazzi Orthopedic Hospital in Milan, among outpatients and healthy volunteers. A brief questionnaire is administered in order to collect data relevant to the CDC Algorithm for Fall Risk Assessment. Then, participants are assessed through the OAK device. The OAK assessment is evaluated in terms of performance, accuracy (in comparison to the CDC Algorithm for Fall Risk Assessment) and safety.
- Conditions
- Postural Imbalance, Gait, Unsteady
- Being tested
- OAK
- Keywords
- Accidental Falls, Risk Assessment, Frail Elderly
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAKDevice
The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.
| Study group | Role | What they receive |
|---|---|---|
| Moderate/High Risk | Experimental | Participants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment Receives: Device: OAK |
| Low Risk | Experimental | Participants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment Receives: Device: OAK |
What is being measured
The primary outcome is the main question the study is designed to answer.
OAK failures in the fall risk assessment
Proportion of participants for which the OAK device is not able to provide a fall risk assessment
Measured: Baseline
OAK sensitivity in the fall risk assessment
Proportion of participants assessed by the OAK device as moderate/high risk of falling among those at moderate/high risk according to the CDC Algorithm for Fall Risk Assessment
Measured: Baseline
Secondary outcomes (3)
Adverse events
Adverse events occurring during the assessment
Measured: Baseline
Serious adverse events
Serious adverse events occurring during the assessment
Measured: Baseline
Rate of falls
Number of falls during the prevoius 6 months
Measured: During the previous 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startNov 2015
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postural ImbalanceStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Banfi, MD, Principal investigator, banfi.giuseppe@fondazionesanraffaele.it
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655796
- Sponsor's protocol ID
- OAK
- Status last verified
- Feb 2017
- First submitted
- 12 Jan 2016
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Castellini G, Gianola S, Stucovitz E, Tramacere I, Banfi G, Moja L. Diagnostic test accuracy of an automated device as a screening tool for fall risk assessment in community-residing elderly: A STARD compliant study. Medicine (Baltimore). 2019 Sep;98(39):e17105. doi: 10.1097/MD.0000000000017105.
PubMed 31574809
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Screening Accuracy of a Device for Fall Risk Assessment in the Elderly: a Cross-sectional Study With a Futility Design
- ClinicalTrials.gov ID
- NCT02655796
- Acronym / sponsor ID
- OAK
- Conditions
- Postural Imbalance, Gait, Unsteady
- Keywords
- Accidental Falls, Risk Assessment, Frail Elderly
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 14 Jan 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.
This study evaluates the screening accuracy of a device (OAK) in assessing fall risk in the elderly, compared to the assessment provided by the Algorithm for Fall Risk Assessment of the Centers for Disease Control and Prevention (CDC).
The OAK device is a technologic system, based on virtual reality. It allows to quickly perform a fall risk assessment integrating clinical indexes of the Brief-BESTest (The Balance Evaluation System Test), and kinematic and posturgraphic indexes. The participants interact with the OAK device through simple exercises, then the device provides an assessment of their functional mobility, equilibrium and postural reactions.
Detailed description
Falls are a serious problem among the elderly. Most falls do not cause death, but 20%-30% of falls result in serious injuries representing a significant source of morbidity and mortality. Good evidence shows that many falls can be prevented. Thus, identifying people with risk of falling is crucial. The aim of this study is the evaluation of the screening accuracy of a device (OAK) in assessing fall risk in the elderly.
Participants are recruited at IRCCS Galeazzi Orthopedic Hospital in Milan, among outpatients and healthy volunteers. A brief questionnaire is administered in order to collect data relevant to the CDC Algorithm for Fall Risk Assessment. Then, participants are assessed through the OAK device. The OAK assessment is evaluated in terms of performance, accuracy (in comparison to the CDC Algorithm for Fall Risk Assessment) and safety.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate/High Risk | Experimental | Device: OAKParticipants assessed as moderate/high risk of falling according to the CDC Algorithm for Fall Risk Assessment |
| Low Risk | Experimental | Device: OAKParticipants assessed as low risk of falling according to the CDC Algorithm for Fall Risk Assessment |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to walk without walking aids.
- Signed informed consent.
Key exclusion criteria (5 listed)
- Neurological, musculoskeletal and orthopaedic disorders limiting mobility function and equilibrium. Psychiatric disorders. Any other medical condition limiting mobility function, as diabetes, obesity, serious ocular disorders (e.g. glaucoma), vestibular disorders (e.g. labyrinthitis) and proprioceptive disorders (e.g. ataxia).
- Pacemaker.
- Surgical interventions for orthopaedic disorders (e.g. knee or hip prosthesis) during the previous 6 months.
- Drug intake altering coordination and equilibrium (e.g. anti-epileptic, sedative-hypnotic drugs).
- Pregnancy.
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 |
|---|---|---|
| OAKThe OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction. | Device | Low Risk, Moderate/High Risk |
Primary outcome
OAK failures in the fall risk assessment
Time frame: Baseline
Proportion of participants for which the OAK device is not able to provide a fall risk assessment
OAK sensitivity in the fall risk assessment
Time frame: Baseline
Proportion of participants assessed by the OAK device as moderate/high risk of falling among those at moderate/high risk according to the CDC Algorithm for Fall Risk Assessment
3 secondary outcomes
Adverse events
Time frame: Baseline
Serious adverse events
Time frame: Baseline
Rate of falls
Time frame: During the previous 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Derived from this study: PubMed 31574809Castellini G, Gianola S, Stucovitz E, Tramacere I, Banfi G, Moja L. Diagnostic test accuracy of an automated device as a screening tool for fall risk assessment in community-residing elderly: A STARD compliant study. Medicine (Baltimore). 2019 Sep;98(39):e17105. doi: 10.1097/MD.0000000000017105.
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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.
Giuseppe Banfi, MD principal investigator
banfi.giuseppe@fondazionesanraffaele.it
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OAK in people with Postural Imbalance and Gait, Unsteady, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 29 Jun 2017. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OAK failures in the fall risk assessment (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655796, which also lists 1 linked publication.
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 29 Jun 2017.