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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02214329
• Other study ID #: 1100000467
• Status: Recruiting
• Phase: N/A
• First received: August 8, 2014
• Last updated: August 11, 2014
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: August 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes

Intervention

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.

Other:
• In-home balance training
The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.

Locations

Country	Name	City	State
United States	University Medical Center	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	Qatar National Research Foundation, Qatar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postural Balance	Postural balance is assess at baseline and post-training using body-worn sensors	6 weeks	No
Primary	Gait	Gait is assessed at baseline and post-training using body-worn sensors	6 weeks	No
Secondary	Physical Activity	Physical activities of daily living are assessed at baseline and post-training using a T-shirt embedded body-worn sensor (PAMSys)	6 weeks	No
Secondary	Functional Performance	Tests, including 3m timed up and go test and alternative step test, are performed. Time is recorded using a stop watch.	6 weeks	No