Wearable Sensor-based Balance Training for Patients With Knee Osteoarthritis

NCT ID: NCT02620462

Last Updated: 2016-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-06-30

Brief Summary

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.

Detailed 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.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

Wearable sensor-based exercise training

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.

Group Type: EXPERIMENTAL

Wearable sensor-based exercise training

Intervention Type: DEVICE

The device provides real-time visual feedback of joint movement during balance exercise

Control Group

The control group only receives standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Wearable sensor-based exercise training

The device provides real-time visual feedback of joint movement during balance exercise

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Bijan Najafi

Associate Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bijan Najafi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

The University of Arizona Arthritis Center

Tucson, Arizona, United States

Countries

United States

Other Identifiers

1501657972

Identifier Type: -

Identifier Source: org_study_id