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Virtual Reality-based Exercise in Older Adults

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ClinicalTrials.gov Identifier: NCT02043834
Recruitment Status : Completed
First Posted : January 23, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Tracking Information
First Submitted Date  ICMJE January 21, 2014
First Posted Date  ICMJE January 23, 2014
Last Update Posted Date July 28, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
Postural Balance [ Time Frame: after 4 weeks ]
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technologies (BalanSens™)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02043834 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2014)
  • Gait performance [ Time Frame: 4 weeks ]
    Gait performance will be measured using validated wearable sensor technology (LEGSys™)
  • Cognitive status [ Time Frame: 4 weeks ]
    Changes in cognitive status will be measured by the Trail Making Test and the Category Fluency Test
  • Quality of life [ Time Frame: 4 weeks ]
  • Functional performance [ Time Frame: 4 weeks ]
    Functional performance will be assessed using the Timed Up and Go Test and the Alternate Step Test
Original Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2014)
  • Gait performance [ Time Frame: 4 weeks ]
    Gait performance will be measured using validated wearable sensor technology (LEGSys™)
  • Cognitive status [ Time Frame: 4 weeks ]
  • Quality of life [ Time Frame: 4 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virtual Reality-based Exercise in Older Adults
Official Title  ICMJE Promoting Virtual Reality-based Exercise to Prevent Falls in Older Adults: Pilot Study
Brief Summary

The aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in older adults.

We hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in older adults compared to a control group receiving usual care only.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Distorted; Balance
  • Motor Deficit
Intervention  ICMJE Other: Balance Training
Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.
Study Arms  ICMJE
  • Experimental: Balance Training
    Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as "ankle reaching" and "obstacle crossing" using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes.
    Intervention: Other: Balance Training
  • No Intervention: Control
    The control group will keep their normal activity without receiving any intervention.
Publications * Schwenk M, Grewal GS, Honarvar B, Schwenk S, Mohler J, Khalsa DS, Najafi B. Interactive balance training integrating sensor-based visual feedback of movement performance: a pilot study in older adults. J Neuroeng Rehabil. 2014 Dec 13;11:164. doi: 10.1186/1743-0003-11-164.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2014)
33
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2014)
30
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ability to ambulate without assistance
  • willingness to provide informed consent

Exclusion Criteria:

  • severe neurologic, cardiovascular, metabolic, or psychiatric disorders
  • severe visual impairment
  • cognitive impairment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02043834
Other Study ID Numbers  ICMJE ARPF-123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bijan Najafi, PhD interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, College of Medicine, University of Arizona
Principal Investigator: Michael Schwenk, PhD interdisciplinary Consortium on Advanced Motion Performance (iCAMP), Department of Surgery, College of Medicine, University of Arizon
PRS Account University of Arizona
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP