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

Not Applicable

• Conditions: Diabetes
• Interventions: Other: In-home balance training; Device: Sensor-based exercise training

• Registration Number: NCT02214329
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-02
• Status Verified: 2014-08
• Study First Submitted: 2014-08-08
• Study First Submitted QC: 2014-08-11
• Last Update Submitted: 2014-08-11
• Study First Posted: 2014-08-12
• Last Update Posted: 2014-08-12
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-home balance training	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.
Sensor-based exercise training	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.

Primary Outcome Measures

Name	Time	Method
Postural Balance	6 weeks	Postural balance is assess at baseline and post-training using body-worn sensors
Gait	6 weeks	Gait is assessed at baseline and post-training using body-worn sensors

Secondary Outcome Measures

Name	Time	Method
Physical Activity	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	6 weeks	Tests, including 3m timed up and go test and alternative step test, are performed. Time is recorded using a stop watch.

Trial Locations

Locations (1)

University Medical Center; 🇺🇸 Tucson, Arizona, United States