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Virtual Reality Based Balance Training in People With Mild Cognitive Impairment

Primary Purpose

Distorted; Balance, Motor Deficit, Cognitive Deficit

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Balance Training
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distorted; Balance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Banner Sun Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Balance Training

Control

Arm Description

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.

The control group will keep their normal activity without receiving any intervention.

Outcomes

Primary Outcome Measures

Postural Balance
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)

Secondary Outcome Measures

Gait performance
Gait performance will be measured using validated wearable sensor technology (LEGSys™)
Cognitive status
Changes in cognitive status will be measured by the Trail Making Test
Fear of falling
Fear of falling will be measured by the Falls Efficacy scale international (short form)
User experience
User experience will be measured using a standardized questionaire
Depressive signs
Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale

Full Information

First Posted
August 8, 2014
Last Updated
December 15, 2014
Sponsor
University of Arizona
Collaborators
Banner Health
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1. Study Identification

Unique Protocol Identification Number
NCT02214342
Brief Title
Virtual Reality Based Balance Training in People With Mild Cognitive Impairment
Official Title
Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arizona
Collaborators
Banner Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distorted; Balance, Motor Deficit, Cognitive Deficit

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balance Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will keep their normal activity without receiving any intervention.
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postural Balance
Description
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Gait performance
Description
Gait performance will be measured using validated wearable sensor technology (LEGSys™)
Time Frame
4 weeks
Title
Cognitive status
Description
Changes in cognitive status will be measured by the Trail Making Test
Time Frame
4 weeks
Title
Fear of falling
Description
Fear of falling will be measured by the Falls Efficacy scale international (short form)
Time Frame
4 weeks
Title
User experience
Description
User experience will be measured using a standardized questionaire
Time Frame
4 weeks
Title
Depressive signs
Description
Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Virtual Reality Based Balance Training in People With Mild Cognitive Impairment

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