Virtual Reality Based Balance Training in People With Mild Cognitive Impairment
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 8, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 16, 2014
December 1, 2014
2 months
August 8, 2014
December 15, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Postural Balance
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)
4 weeks
Secondary Outcomes (5)
Gait performance
4 weeks
Cognitive status
4 weeks
Fear of falling
4 weeks
User experience
4 weeks
Depressive signs
4 weeks
Study Arms (2)
Balance Training
EXPERIMENTALBalance 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.
Control
NO INTERVENTIONThe control group will keep their normal activity without receiving any intervention.
Interventions
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.
Eligibility Criteria
You may qualify if:
- diagnosis of Mild Cognitive Impairment
- willingness to provide informed consent
You may not qualify if:
- severe neurologic, cardiovascular, metabolic, or psychiatric disorders
- severe visual impairment
- severe cognitive impairment
- dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- Banner Healthcollaborator
Study Sites (1)
Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bijan Najafi, PhD
University of Arizona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2014
First Posted
August 12, 2014
Study Start
July 1, 2014
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 16, 2014
Record last verified: 2014-12