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Clinical Trials/NCT04324333
NCT04324333
Recruiting
Not Applicable

Modelling Missteps to Improve Fall Risk Assessment.

Tel-Aviv Sourasky Medical Center1 site in 1 country200 target enrollmentSeptember 9, 2019
ConditionsFall Patients

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fall Patients
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
200
Locations
1
Primary Endpoint
Physical Activity
Status
Recruiting
Last Updated
6 years ago

Overview

Brief 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 time of the incident, without the need for an emergency / distress button or making a phone call.

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.

Registry
clinicaltrials.gov
Start Date
September 9, 2019
End Date
December 31, 2024
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Physical Activity

Time Frame: One week post monitoring period

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

Community ambulation

Time Frame: One week post monitoring period

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

The frequency of falling

Time Frame: One week post monitoring period

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

Secondary Outcomes

  • Improve in motor function(One week post monitoring period)
  • Changes in endurance(One week post monitoring period)

Study Sites (1)

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