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

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ClinicalTrials.gov Identifier: NCT02214329
Recruitment Status : Unknown
Verified August 2014 by University of Arizona.
Recruitment status was:  Recruiting
First Posted : August 12, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborator:
Qatar National Research Foundation, Qatar
Information provided by (Responsible Party):
University of Arizona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Device: Sensor-based exercise training Other: In-home balance training Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes
Study Start Date : February 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Postural Balance [ Time Frame: 6 weeks ]
    Postural balance is assess at baseline and post-training using body-worn sensors

  2. Gait [ Time Frame: 6 weeks ]
    Gait is assessed at baseline and post-training using body-worn sensors


Secondary Outcome Measures :
  1. 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)

  2. 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.



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214329


Locations
United States, Arizona
University Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: David G Armstrong, DPM, MD, PhD    520-626-1349    dga@email.arizona.edu   
Contact: Bijan Najafi, PhD    520 626 7097    bnajafi@surgery.arizona.edu   
Principal Investigator: David G Armstrong, DPM, MD, PhD         
Sponsors and Collaborators
University of Arizona
Qatar National Research Foundation, Qatar

Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT02214329     History of Changes
Other Study ID Numbers: 1100000467
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014

Keywords provided by University of Arizona:
Postural Balance
Gait
Fall risk

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases