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

University of Arizona

Status: Unknown

Conditions: Diabetes

Treatments: Other: In-home balance training; Device: Sensor-based exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT02214329

1100000467

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Sensor-based exercise training

Experimental group

Description:

The intervention group receives sensor-based balance training with real-time joint feedback through an interactive interface on LC monitor screen.

Treatment:

Device: Sensor-based exercise training

In-home balance training

Active Comparator group

Description:

The control group performs similar exercise as intervention group at home without use of sensor or any joint feedback from sensor data.

Treatment:

Other: In-home balance training