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Fall PatientsNCT04324333

Modelling Missteps to Improve Fall Risk Assessment.

A study testing Digital wearable system in people with Fall Patients, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The long-term goals of the project are: 1) Preventing falls before they occur, by significantly improving our ability to monitor fall risk and develop early and sensitive markers for this risk, based on tripping and near falls and other physiological signs, 2) automatically diagnosing falls within seconds from the… Read more about this study

Who is it for?
Ages 65 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Fall Patients
What is being tested?
Digital wearable system
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteIsrael
Study dates
9 Sep 2019to 31 Dec 2024
Phase
Interventional
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 65-90 years old;
  • Ambulatory without help from another person (with or without use of walking aid);
  • Able to follow simple directions (Mini Mental State Examination score >21);
  • Community-living or assisted living housing for elderly.

Who cannot join

  • Subjects who will not be able to wear the devices for more than a 1 week period during the 4 months following their baseline evaluation (planning on traveling out of town, etc.);
  • Patients who are not able to deal with the device and do not family member or therapist who is willing to help with the system;
  • A state of health that does not allow participation in research and testing, or who has not agreed to participate in the study, or is unable to understand and follow simple instructions.

Trial locations and contacts

1 site in 1 country.

Marina Brozol, Ms contact

+972-3-6947513

marinab@tlvmc.gov.il

Israel1 site, 1 recruiting

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

    Jeffrey M Hausdorff, Prof., +972-3-6947513, jhausdor@tlvmc.gov.il

    Marina Brozgol, +972-3-6947513, marinab@tlvmc.gov.il

    Recruiting

Other trials in Israel

About this study

The long-term goals of the project are: 1) Preventing falls before they occur, by significantly improving our ability to monitor fall risk and develop early and sensitive markers for this risk, based on tripping and near falls and other physiological signs, 2) automatically diagnosing falls within seconds from the time of the incident, without the need for an emergency / distress button or making a phone call.

Read the detailed description

All subjects will be asked to come to the Center for the Study of Movement, Cognition and Mobility (CMCM), where they will undergo baseline testing. This initial evaluation is designed 1) to assess each subject's mobility, fall risk and related functions, and 2) to obtain more specific information that will be used to inform and update the model of falls and missteps detection.

The study is divided into 3 sections:

  1. First session in Gait Lab (CMCM) for an overall assessment of subject health (see below).
  2. Using the system ("monitoring ADL period") in daily life for 4 months (system: Owlytics Healthcare's app+wearable wristband \& insoles).
  3. A concluding session where the mobility tests performed at the beginning of the study are repeated to assess the changes that occurred during the a period in which the monitoring system is used.

During the first session medical data will be recorded, such as demographics (age, gender, years of education, etc.), habits (physical activity, leisure activities, dietary habits), daily life activities, health-related behaviors (e.g., alcohol consumption and smoking history) and so.

Medical examination will include standardized walking tests (usual-walking and dual-task walking), eye examination, hearing test, balance tests, etc. In addition, to assess cognitive abilities standard Neuropsychological Battery will be used.

At the end of the session, the participant will be asked to place a small accelerometer (AX6 - 6-Axis Logging Accelerometer) to measure daily activity for 7 days. The device will be attached to the lower back using a medical patch. The sensor is lightweight, non-invasive and does not endanger subject's health in any way.

The second part of the study (or "monitoring ADL period") - after the initial assessment, the research coordinator will instruct the subject to use the system. As mentioned, the system is given for 4 months.

The participant will be requested to complete a "fall log" for tracking (via mail, e-mail, phone call or fax).

If the system detects a fall or tripping event, one of the research team will contact the participant to verify the incident and get information about its circumstances (e.g., what the subject did at that time) and the consequences (e.g., does this require medical attention). Any health changes will also be documented during the follow-up period.

Part Three - repeats the tests to assess the changes that occurred during the monitoring period.

Conditions
Fall Patients
Being tested
Digital wearable system
Keywords
Falls, Falls Prevention in Older Age, Automated detection of missteps, Fall Risk

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital wearable systemBehavioural

    Also called Digital wearable system (Owlytics Healthcare's app)

    Owlytics Healthcare's system is dedicated to improving the lives of all seniors by using the predictive power of data analytics.

Study groups in NCT04324333
Study groupRoleWhat they receive
Using Digital wearable system for fall detectionExperimentalDigital wearable system (Owlytics Healthcare's app) enables a 24/7 health-tracking service, collecting personal health data from wearable wristbands and insoles. The data is analyzed by machine-learning algorithms that can detect abnormal physiological patterns. This allows the prediction and prevention of potentially harmful health events (such as falls).
Receives: Behavioral: Digital wearable system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Activity

    The International Physical Activity Questionnaires (IPAQ-short). It will quantify the health-related physical activity.

    Measured: One week post monitoring period

  2. Community ambulation

    A body-worn small lightweight device (6-Axis Logging Accelerometer) that will be worn by the subject for 7 days to monitor ADL.

    Measured: One week post monitoring period

  3. The frequency of falling

    The subjects are asked to fill in monthly Fall log (Frequency and circumstances of falls if occurred)

    Measured: One week post monitoring period

Secondary outcomes (2)

  1. Changes in endurance

    This measure will be assessed using the 2 minute walk test. The distance walked during 2 minutes will be compared to baseline performance.

    Measured: One week post monitoring period

  2. Improve in motor function

    Timed Up \& Go test scores (will be compared to baseline performance).

    Measured: One week post monitoring period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start9 Sep 2019
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04324333
Sponsor's protocol ID
TASMC-18-NG-0646-CTIL
Status last verified
Mar 2020
First submitted
23 Mar 2020
Last updated
31 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Hausdorff JM, Rios DA, Edelberg HK. Gait variability and fall risk in community-living older adults: a 1-year prospective study. Arch Phys Med Rehabil. 2001 Aug;82(8):1050-6. doi: 10.1053/apmr.2001.24893.

    PubMed 11494184

  • Mackenzie L, Byles J, D'Este C. Validation of self-reported fall events in intervention studies. Clin Rehabil. 2006 Apr;20(4):331-9. doi: 10.1191/0269215506cr947oa.

    PubMed 16719031

Questions about this trial

What is this clinical trial studying?

A study testing Digital wearable system in people with Fall Patients, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.

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 31 Mar 2020. 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 Israel. 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 Marina Brozol, Ms (+972-3-6947513, marinab@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Activity (time frame: One week post monitoring period). The study lists 3 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 NCT04324333, which also lists 2 linked publications.

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 31 Mar 2020.

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