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Virtual Reality Based Balance Training in People With Mild Cognitive Impairment

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ClinicalTrials.gov Identifier: NCT02214342
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : December 16, 2014
Sponsor:
Collaborator:
Banner Health
Information provided by (Responsible Party):
University of Arizona

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 people with mild cognitive impairment.

The investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.


Condition or disease Intervention/treatment Phase
Distorted; Balance Motor Deficit Cognitive Deficit Other: Balance Training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study
Study Start Date : July 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
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.
Other: Balance Training
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.

No Intervention: Control
The control group will keep their normal activity without receiving any intervention.



Primary Outcome Measures :
  1. Postural Balance [ Time Frame: 4 weeks ]
    Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)


Secondary Outcome Measures :
  1. Gait performance [ Time Frame: 4 weeks ]
    Gait performance will be measured using validated wearable sensor technology (LEGSys™)

  2. Cognitive status [ Time Frame: 4 weeks ]
    Changes in cognitive status will be measured by the Trail Making Test

  3. Fear of falling [ Time Frame: 4 weeks ]
    Fear of falling will be measured by the Falls Efficacy scale international (short form)

  4. User experience [ Time Frame: 4 weeks ]
    User experience will be measured using a standardized questionaire

  5. Depressive signs [ Time Frame: 4 weeks ]
    Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of Mild Cognitive Impairment
  • willingness to provide informed consent

Exclusion Criteria:

  • severe neurologic, cardiovascular, metabolic, or psychiatric disorders
  • severe visual impairment
  • severe cognitive impairment
  • dementia

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): NCT02214342


Locations
United States, Arizona
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
Sponsors and Collaborators
University of Arizona
Banner Health
Investigators
Principal Investigator: Bijan Najafi, PhD University of Arizona

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02214342     History of Changes
Other Study ID Numbers: 1401199972
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders