Virtual Reality Based Balance Training in People With Mild Cognitive Impairment

Study Overview
=================
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.

Official Title
-----------------
Virtual Reality Based Balance Training in People With Mild Cognitive Impairment: A Pilot Study

Conditions
-----------------
Distorted; Balance, Motor Deficit, Cognitive Deficit

Intervention / Treatment
-----------------
* Other: Balance Training


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Balance Training<br>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<br>* 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.<br>|
| No Intervention: Control<br>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 | 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 | Gait performance will be measured using validated wearable sensor technology (LEGSys™) | 4 weeks | 
| Cognitive status | Changes in cognitive status will be measured by the Trail Making Test | 4 weeks | 
| Fear of falling | Fear of falling will be measured by the Falls Efficacy scale international (short form) | 4 weeks | 
| User experience | User experience will be measured using a standardized questionaire | 4 weeks | 
| Depressive signs | Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale | 4 weeks |