Virtual Reality Based Balance Training in People With Mild Cognitive Impairment

Cognitive Deficit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02214342
• Other study ID #: 1401199972
• Status: Completed
• Phase: N/A
• First received: August 8, 2014
• Last updated: December 15, 2014
• Start date: July 2014
• Est. completion date: September 2014

Study information

• Verified date: December 2014
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Distorted; Balance
• Mild Cognitive Impairment
• Motor Deficit

Intervention

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.

Locations

Country	Name	City	State
United States	Banner Sun Health Research Institute	Sun City	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Banner Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural Balance	Postural Balance during quiet standing for 30 seconds will be assessed using validated wearable sensor technology (BalanSens™)	4 weeks	No
Secondary	Gait performance	Gait performance will be measured using validated wearable sensor technology (LEGSys™)	4 weeks	No
Secondary	Cognitive status	Changes in cognitive status will be measured by the Trail Making Test	4 weeks	No
Secondary	Fear of falling	Fear of falling will be measured by the Falls Efficacy scale international (short form)	4 weeks	No
Secondary	User experience	User experience will be measured using a standardized questionaire	4 weeks	No
Secondary	Depressive signs	Depressive signs will be measured using the Center for Epidemiologic Studies Depression Scale	4 weeks	No