Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-27 @ 10:55 PM
Study NCT ID:
NCT04324333
Status:
UNKNOWN
Last Update Posted:
2020-03-31
First Post:
2020-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Modelling Missteps to Improve Fall Risk Assessment.
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official Title:
Modelling Missteps to Improve Fall Risk Assessment.
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: