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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Sensor-based exercise training
* Other: In-home balance training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensor-based exercise training<br>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<br>* Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.<br>|
| Active Comparator: In-home balance training<br>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<br>* The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postural Balance, Gait, Fall risk