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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
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:

  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
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, see Learn About Clinical Studies.

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 October 29, 2014