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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02043834
Other study ID # ARPF-123
Secondary ID
Status Completed
Phase N/A
First received January 21, 2014
Last updated July 25, 2014
Start date November 2013
Est. completion date June 2014

Study information

Verified date July 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 older adults.

We hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in older adults compared to a control group receiving usual care only.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date June 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- ability to ambulate without assistance

- willingness to provide informed consent

Exclusion Criteria:

- severe neurologic, cardiovascular, metabolic, or psychiatric disorders

- severe visual impairment

- cognitive impairment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
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 Villa Hermosa - Senior Living Tucson Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
University of Arizona

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 technologies (BalanSens™) after 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 and the Category Fluency Test 4 weeks No
Secondary Quality of life 4 weeks No
Secondary Functional performance Functional performance will be assessed using the Timed Up and Go Test and the Alternate Step Test 4 weeks No
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