Clinical trial NCT02620462: Wearable Sensor-based Balance Training for Patients With Knee Osteoarthritis
Official title: Explore the Effectiveness of a Sensor-based Interactive Exercise Training on Functional Performance in Patients With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Postural Balance
Pain
Gait
Physical Activity Level
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2015-12-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Body Sway as an indicator of postural control
timeFrame: 6 weeks
Secondary outcomes:
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: 6 weeks
measure: Gait
timeFrame: 6 weeks
measure: Pain
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: The University of Arizona Arthritis Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Bijan Najafi, PhD
role: PRINCIPAL_INVESTIGATOR
References: