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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01668979
First Posted: August 20, 2012
Last Update Posted: August 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
  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

Resource links provided by NLM:


Further study details as provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • usability of the system to detect Near Falls [ Time Frame: one year ]

Secondary Outcome Measures:
  • Near Fall severity [ Time Frame: one year ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy older adults with a history of falls
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 16, 2012
First Posted: August 20, 2012
Last Update Posted: August 20, 2012
Last Verified: August 2012