This trial is active, not recruiting.

Condition knee osteoarthritis
Treatment wearable sensor-based exercise training
Sponsor University of Arizona
Start date February 2015
End date March 2017
Trial size 24 participants
Trial identifier NCT02620462, 1501657972


Knee osteoarthritis (KOA) is one of the leading causes of lower limb disability among the elderly and can cause loss of knee joint proprioception that contributes towards deterioration of postural balance. Maintaining a good postural stability is essential while performing everyday functional activities and to avoid falls. Exercise training has been reported to reduce pain as well as improve performance of functional tasks in patients with KOA however compliance to exercise can be challenging due to pain, lack of motivation and traditional nature of exercise that can easily overtax patients. Furthermore, there are not exercise programs that are specifically designed for patients with KOA in order to address lost knee joint proprioception. Recent studies have also demonstrated that visual feedback during exercise can enhance the benefits of exercise training. Therefore, the aim of the proposed study is to implement an interactive sensor-based exercise training to improve postural balance, gait and activities of daily living in patients with KOA.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
The intervention group in addition to standard of care, will receive 6 weeks of sensor-based balance training that provides real-time visual feedback of lower extremities during exercise. The visual feedback is provided on computer screen.
wearable sensor-based exercise training
The device provides real-time visual feedback of joint movement during balance exercise
(No Intervention)
The control group only receives standard of care.

Primary Outcomes

Body Sway as an indicator of postural control
time frame: 6 weeks

Secondary Outcomes

Knee injury and Osteoarthritis Outcome Score
time frame: 6 weeks
time frame: 6 weeks
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - age 18 and above - ability to walk 50 m independently (with or without aid) - ability to stand for 5 minutes . Exclusion Criteria: - disorder other than osteoarthritis that may severely affect gait and balance

Additional Information

Official title Explore the Effectiveness of a Sensor-based Interactive Exercise Training on Functional Performance in Patients With Knee Osteoarthritis
Principal investigator Bijan Najafi, PhD
Description The exercise intervention procedure is based on wearable sensor game-based balance-training program (Exergame). Subjects will perform progressive balance exercises such as ankle reaching or weight shifting, obstacle crossing, and ankle trail making task (i.e. motor-cognitive task). Real-time visual/audio lower-extremity joint motion feedback will be provided using wearable sensors (LEGSys, Biosensics LLC, Cambridge, MA, USA) to assist and encourage subjects to accurately execute each exercise task. The same wearable sensor technology is also used to quantify changes in balance and gait. Changes in balance, gait, fear of falling, physical activity, pain, and quality of life parameters will be assessed at the beginning and conclusion of the training program. Subjects will perform sensor-based interactive balance training (on computer screen), 2 x week, for a period of 6 weeks. The training consists of three balance tasks shown on a computer screen (1. ankle reaching task or weight shifting , 2. obstacle negotiation task, and 3. ankle trail making task (i.e. motor-cognitive task) intended to improve postural stability.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Arizona.