Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm
Game-Based Virtual Reality Approach for Improving Balance, Reducing Falls, and Preventing Complications In Diabetes
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 8, 2014
CompletedFirst Posted
Study publicly available on registry
August 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 12, 2014
August 1, 2014
1.5 years
August 8, 2014
August 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Postural Balance
Postural balance is assess at baseline and post-training using body-worn sensors
6 weeks
Gait
Gait is assessed at baseline and post-training using body-worn sensors
6 weeks
Secondary Outcomes (2)
Physical Activity
6 weeks
Functional Performance
6 weeks
Study Arms (2)
Sensor-based exercise training
EXPERIMENTALThe intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen.
In-home balance training
ACTIVE COMPARATORThe control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data.
Interventions
Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.
The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.
Eligibility Criteria
You may qualify if:
- Diabetic peripheral neuropathy
- Age \> 50 (Men or Women)
- Able to walk 60 feet
You may not qualify if:
- Major lower extremity amputation
- Cognitive deficits (MMSE 24 or below)
- Severely impaired vision
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Arizonalead
- Qatar National Research Foundation, Qatarcollaborator
Study Sites (1)
University Medical Center
Tucson, Arizona, 85724, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2014
First Posted
August 12, 2014
Study Start
February 1, 2014
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
August 12, 2014
Record last verified: 2014-08