Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm

August 11, 2014 updated by: University of Arizona

Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes

Diabetic peripheral neuropathy (DPN) can severely deteriorate balance and gait in patients, thereby increasing risk of fall and injury. The aim of the study is to evaluate the efficacy of a virtual reality game based exercise training for improving postural body sway and gait in diabetes patients with peripheral neuropathy. The exercise training has been specifically designed for DPN patients with lost lower extremity joint perception and uses state-of-the-art inertial sensors (body-worn) to acquire joint movement and provide real-time joint feedback through an interactive interface on a LCD monitor. The investigators hypothesize that tailored exercise with real-time visual joint feedback during exercise will reduce improve balance and gait.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The game includes a series of ankle reaching tasks and crossing of virtual obstacles on the monitor screen; these exercises are aimed to improve weight shifting capabilities and medial-lateral movement of body.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • David G Armstrong, DPM, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diabetic peripheral neuropathy
  • Age > 50 (Men or Women)
  • Able to walk 60 feet

Exclusion Criteria:

  • Major lower extremity amputation
  • Cognitive deficits (MMSE 24 or below)
  • Severely impaired vision

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sensor-based exercise training
The intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen.
Device: Sensor-based exercise training
Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.
Active Comparator: In-home balance training
The control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data.
Other: In-home balance training
The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postural Balance
Time Frame: 6 weeks
Postural balance is assess at baseline and post-training using body-worn sensors
6 weeks
Gait
Time Frame: 6 weeks
Gait is assessed at baseline and post-training using body-worn sensors
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: 6 weeks
Physical activities of daily living are assessed at baseline and post-training using a T-shirt embedded body-worn sensor (PAMSys)
6 weeks
Functional Performance
Time Frame: 6 weeks
Tests, including 3m timed up and go test and alternative step test, are performed. Time is recorded using a stop watch.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

Qatar National Research Foundation, Qatar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 8, 2014

First Submitted That Met QC Criteria

August 11, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1100000467

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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