- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214342
Virtual Reality Based Balance Training in People With Mild Cognitive Impairment
Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arizona
-
Sun City, Arizona, United States, 85351
- Banner Sun Health Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postural Balance
Time Frame: 4 weeks
|
Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gait performance
Time Frame: 4 weeks
|
Gait performance will be measured using validated wearable sensor technology (LEGSys™)
|
4 weeks
|
Cognitive status
Time Frame: 4 weeks
|
Changes in cognitive status will be measured by the Trail Making Test
|
4 weeks
|
Fear of falling
Time Frame: 4 weeks
|
Fear of falling will be measured by the Falls Efficacy scale international (short form)
|
4 weeks
|
User experience
Time Frame: 4 weeks
|
User experience will be measured using a standardized questionaire
|
4 weeks
|
Depressive signs
Time Frame: 4 weeks
|
Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale
|
4 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1401199972
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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