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

Idiopathic Fallers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01668979
• Other study ID #: TASMC-12-NG-0363-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: August 16, 2012
• Last updated: August 16, 2012
• Start date: September 2012
• Est. completion date: September 2013

Study information

• Verified date: August 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nir Giladi, MD
• Phone: +972 3 6974958
• Email: nirg[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Idiopathic Fallers

Intervention

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

Locations

Country	Name	City	State
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	usability of the system to detect Near Falls		one year	No
Secondary	Near Fall severity		one year	No