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Wearable Sensor-based Balance Training for Patients With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wearable sensor-based exercise training
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Osteoarthritis focused on measuring Postural Balance, Pain, Gait, Physical Activity Level

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Arizona Arthritis Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wearable sensor-based exercise training

Control Group

Arm Description

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.

The control group only receives standard of care.

Outcomes

Primary Outcome Measures

Body Sway as an indicator of postural control
Body sway including ankle sway, hip sway, and center of mass sway

Secondary Outcome Measures

Knee injury and Osteoarthritis Outcome Score
Knee injury and Osteoarthritis Outcome Score measured by KOOS
Gait
Spatio-temporal parameters of gait including gait speed, double support, and stride length
Pain
Pain intensity will be assessed using visual analogue scale

Full Information

First Posted
June 8, 2015
Last Updated
May 16, 2016
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT02620462
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Postural Balance, Pain, Gait, Physical Activity Level

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Wearable sensor-based exercise training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group only receives standard of care.
Intervention Type
Device
Intervention Name(s)
Wearable sensor-based exercise training
Intervention Description
The device provides real-time visual feedback of joint movement during balance exercise
Primary Outcome Measure Information:
Title
Body Sway as an indicator of postural control
Description
Body sway including ankle sway, hip sway, and center of mass sway
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Knee injury and Osteoarthritis Outcome Score
Description
Knee injury and Osteoarthritis Outcome Score measured by KOOS
Time Frame
6 weeks
Title
Gait
Description
Spatio-temporal parameters of gait including gait speed, double support, and stride length
Time Frame
6 weeks
Title
Pain
Description
Pain intensity will be assessed using visual analogue scale
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bijan Najafi, PhD
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Arizona Arthritis Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85713
Country
United States

12. IPD Sharing Statement

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Wearable Sensor-based Balance Training for Patients With Knee Osteoarthritis

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