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

NCT ID: NCT02214329

Last Updated: 2014-08-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-12-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensor-based exercise training

Intervention Type: DEVICE

Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise 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.

Group Type: ACTIVE_COMPARATOR

In-home balance training

Intervention Type: OTHER

The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.

Interventions

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.

Intervention Type: DEVICE

In-home balance training

The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qatar National Research Foundation, Qatar

UNKNOWN

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

David G Armstrong, DPM, MD, PhD

Role: primary

dga@email.arizona.edu

520-626-1349

Bijan Najafi, PhD

Role: backup

bnajafi@surgery.arizona.edu

520 626 7097

Other Identifiers

1100000467

Identifier Type: -

Identifier Source: org_study_id