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

This study is not yet open for participant recruitment.

Verified August 2012 by Tel-Aviv Sourasky Medical Center

Sponsor:

Information provided by (Responsible Party):

Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center

ClinicalTrials.gov Identifier:

NCT01668979

First received: August 16, 2012

Last updated: NA

Last verified: August 2012

History: No changes posted

Purpose

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.

Condition	Intervention
Idiopathic Fallers	Device: new system to detect Near Falls

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Cross-Sectional
Official Title:	Assessment of a New System to Detect, Quantify and Treat Near Falls in Older Adults

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:

usability of the system to detect Near Falls [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Near Fall severity [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2012
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	60 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy older adults with a history of falls

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668979

Contacts

Contact: Nir Giladi, MD	+972 3 6974958	nirg@tasmc.health.gov.il
Contact: Anat Mirelman, PhD	+972 3 6973960	anatmi@tasmc.health.gov.il

Locations

Israel
Tel Aviv Sourasky Medical Center	Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Nir Giladi, MD +972 3 6974958 nirg@tasmc.health.gov.il
Sub-Investigator: Anat Mirelman, PhD

Sponsors and Collaborators

Tel-Aviv Sourasky Medical Center

Investigators

Principal Investigator:

Nir Giladi, MD

Tel-Aviv Sourasky Medical Center

More Information

No publications provided

Responsible Party:	Michal Roll PhD,MBA, Director of Research and Development, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:	NCT01668979 History of Changes
Other Study ID Numbers:	TASMC-12-NG-0363-CTIL
Study First Received:	August 16, 2012
Last Updated:	August 16, 2012
Health Authority:	Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 22, 2013

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