Recruiting

Balance Training

Sponsor:

University of Arizona

Code:

NCT02214329

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Sensor-based exercise training

In-home balance training

Study Details

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.

Conditions

Diabetes

Study ID

NCT02214329

Start date

Feb, 2014

Status verified date

Aug, 2014

Completion date

Dec, 2015

Anticipated

Primary completion date

Aug, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

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.

In-home balance training

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

Primary outcome measure

  • Postural Balance [ Time Frame: 6 weeks ]
  • Gait [ Time Frame: 6 weeks ]

Central Contacts and Locations

Locations

University Medical Center

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Principal Investigator:

David G Armstrong, DPM, MD, PhD

More Information

Sponsor

University of Arizona

Last update posted

Aug 12, 2014

Last verified

Aug, 2014

Keywords

  • Postural Balance
  • Gait
  • Fall risk

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2014-08-12.