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

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.

Study Overview

• Status: Unknown
• Conditions: Idiopathic Fallers
• Intervention / Treatment: Device: new system to detect Near Falls

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy older adults with a history of falls

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
new system to detect Near Falls; 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.	Device: new system to detect Near Falls; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
usability of the system to detect Near Falls	one year

Secondary Outcome Measures

Outcome Measure	Time Frame
Near Fall severity	one year

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Nir Giladi, MD, Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2013
• Study Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: August 16, 2012
• First Submitted That Met QC Criteria: August 16, 2012
• First Posted (Estimate): August 20, 2012

Study Record Updates

• Last Update Posted (Estimate): August 20, 2012
• Last Update Submitted That Met QC Criteria: August 16, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: TASMC-12-NG-0363-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No