## Protocol Section
### Identification Module
**NCT ID:** NCT01668979

**Brief Title:** Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

**Official Title:** Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

#### Organization Study ID Info
**ID:** TASMC-12-NG-0363-CTIL
#### Organization
**Class:** OTHER_GOV
**Full Name:** Tel-Aviv Sourasky Medical Center
### Status Module
#### Completion Date
**Date:** 2013-09

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2012-08-20

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-08-16

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-09

**Status Verified Date:** 2012-08

#### Study First Post Date
**Date:** 2012-08-20
**Type:** ESTIMATED
**Study First Submit Date:** 2012-08-16
**Study First Submit QC Date:** 2012-08-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Tel-Aviv Sourasky Medical Center

#### Responsible Party

**Investigator Affiliation:** Tel-Aviv Sourasky Medical Center

**Investigator Full Name:** Michal Roll PhD,MBA

**Investigator Title:** Director of Research and Development

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The study is aimed to assess a new system for the automatic detection, quantification and treatment of Near Fall (NF) episodes in healthy older adults with a history of falls. The system is comprized of a treadmill and a virtual reality simulation which provides a motor-cognitive challenge to provoke NF. The challenges provided by the system are individualized and using machine learning algorithms will enable the identification and detection of NF under different conditions and allow for the most suitable treatment.

### Conditions Module

**Conditions:**

- Idiopathic Fallers

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** CROSS_SECTIONAL

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** the new system comprises of a treadmill and a virtual reality simulation that will be used to induce Near Falls in healthy older adults with a history of falls.

**Intervention Names:**

- Device: new system to detect Near Falls

**Label:** new system to detect Near Falls

### Interventions

#### Intervention 1

**Arm Group Labels:**

- new system to detect Near Falls

**Description:** We will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes

**Name:** new system to detect Near Falls

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** usability of the system to detect Near Falls

**Time Frame:** one year

#### Secondary Outcomes

**Measure:** Near Fall severity

**Time Frame:** one year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Healthy older adults with a history of falls or complaints of gait instability
2. Able to walk independently for at least 10 minutes

Exclusion Criteria:

1. Systemic chronic or acute pathologies:

   1. Ischemic heart disease
   2. Orthopedic or Rheumatic diseases
   3. Severe vision problems
   4. Neurological disease: PD, AD, CVA
2. Patients who underwent brain surgery in the last 6 months prior to the study

**Healthy Volunteers:** True

**Maximum Age:** 85 Years

**Minimum Age:** 60 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Healthy older adults with a history of falls

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** nirg@tasmc.health.gov.il

**Name:** Nir Giladi, MD

**Phone:** +972 3 6974958

**Role:** CONTACT

**Contact 2:**

**Email:** anatmi@tasmc.health.gov.il

**Name:** Anat Mirelman, PhD

**Phone:** +972 3 6973960

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Tel Aviv

**Contacts:**

***Contact 1:***

- **Email:** nirg@tasmc.health.gov.il

- **Name:** Nir Giladi, MD

- **Phone:** +972 3 6974958

- **Role:** CONTACT

***Contact 2:***

- **Name:** Anat Mirelman, PhD

- **Role:** SUB_INVESTIGATOR

**Country:** Israel

**Facility:** Tel Aviv Sourasky Medical Center

**Zip:** 64239

#### Overall Officials

**Official 1:**

**Affiliation:** Tel-Aviv Sourasky Medical Center

**Name:** Nir Giladi, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-24
