Sensor-based Balance Training in Diabetes: A Virtual Reality Paradigm
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Diabetes||Device: Sensor-based exercise training Other: In-home balance training||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- Postural Balance [ Time Frame: 6 weeks ]Postural balance is assess at baseline and post-training using body-worn sensors
- Gait [ Time Frame: 6 weeks ]Gait is assessed at baseline and post-training using body-worn sensors
- 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)
- 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.
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
|United States, Arizona|
|University Medical Center||Recruiting|
|Tucson, Arizona, United States, 85724|
|Contact: David G Armstrong, DPM, MD, PhD 520-626-1349 firstname.lastname@example.org|
|Contact: Bijan Najafi, PhD 520 626 7097 email@example.com|
|Principal Investigator: David G Armstrong, DPM, MD, PhD|