Validity And Reliability of Wearable Motion Sensors in Knee Joint Range of Motion Measurement

Objective: The aim of this study is to examine the validity and reliability of a wearable motion sensor, which is an inertial measurement units (IMUs) sensor, in measuring knee joint active flexion movement angles.

Methods: The study included 70 Health Sciences Faculty students between the ages of 18-25. The dominant knee joint range of motion of the participants was measured by two raters with a digital goniometer (Meloq EasyAngle) and wearable motion sensors (MetaMotionRL). A 10-minute rest was given between each measurement. The data were analyzed using the IBM® SPSS® Statistics for Windows software (Version 27.0). Mean ± standard deviation (Mean ± SD) and percentage (%) were used for the descriptive variables. Intra- and inter-rater reliability was tested with intraclass correlation coefficient (ICC) and Bland-Altman analysis. ICC values less than 0.5 were classified as poor, values between 0.5 and 0.75 as moderate, values between 0.75 and 0.9 as good, and values greater than 0.90 as excellent reliability. Paired samples t test was used to compare test-retest measurements. Concurrent validity was determined by Pearson correlation coefficient. The significance value was accepted as p<0.05.

Study Overview

• Status: Completed
• Conditions: Range of Motion; Knee

Detailed Description

Before knee range of motion measurements, all participants were given verbal information about the measurements. Participants were asked to wear shorts that exposed their knees. While the participants were lying in the prone position on the examination table, their dominant knee range of motion was measured with both EasyAngle and MetaMotionRL by two different physiotherapists.

EasyAngle digital goniometer and universal goniometer measurement results were compared and it was concluded that EasyAngle is a valid and reliable evaluation tool.

MetaMotionRL (MBientlab Inc., San Francisco, USA); Includes 9-axis inertial measurement units and environmental monitoring sensor. It features gyroscope, accelerometer, magnetometer and sensor fusion. Real-time communication is provided via BluetoothLE. Data can also be saved to 8 megabyte NOR flash memory. There are free, open-source applications and applications for fast data collection.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34445
    • Halic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Seventy healthy student were included between December 2021 and April 2022, the study was approved by Haliç University Non-Invasive Ethics Committee (173/01.12.2021). All participants completed written informed consent. Seventy healthy students (40 female, 30 male) from Haliç University Faculty of Health Sciences were included in the study.

Description

Inclusion Criteria:

• being between the ages of 18-25
• volunteering to participate in the study

Exclusion Criteria:

• a history of orthopedic surgery or trauma to the lower extremity
• knee pain felt during joint range of motion measurement
• inability to maintain a prone position

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital goniometer measurement	Participants were asked to wear shorts that exposed their knees. While the participants were lying in the prone position on the examination table, their dominant knee range of motion was measured with EasyAngle (Meloq©, Stockholm, Sweden) digital goniometer by physiotherapists (rater I). The participant was instructed to bend his knee and bring his heel as close to his hip as possible. The degree of dominant knee active flexion was measured three times by the rater I with a EasyAngle (Meloq©, Stockholm, Sweden) digital goniometer (the pivot point was determined as the lateral epicondyle of the femur), and the highest value was recorded.	at baseline
MetaMotionRLs measurement	Two MetaMotionRLs were fixed to the lateral thigh and leg with velcro strap, at the level of the midpoint of the tibia and femur in the dominant lower extremity by the rater I. Two MetaMotionRL motion sensors were used simultaneously. MetaMotionRL was used by connecting via Bluetooth with the free MetaROM (application) smart phone application. The participant was asked to flex his knee as much as possible. Three measurements were made and the highest value shown in the app was recorded. Following this, the sensors were removed and placed again after 10 minutes and measured a second time by the same rater using the same method, the highest value was recorded. Following removal of the sensors, the participant was taken to a different examination table in the same room. And the rater II placed the sensors and repeated the MetaMotionRL measurement.	at baseline

Collaborators and Investigators

• Sponsor: Halic University
• Investigators: Study Director: Melek Güneş Yavuzer, Prof., Halic University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2021
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: July 28, 2024
• First Submitted That Met QC Criteria: August 1, 2024
• First Posted (Estimated): August 5, 2024

Study Record Updates

• Last Update Posted (Estimated): August 5, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Wearable motion sensors; MetamotionRL; IMUs
• Other Study ID Numbers: Acetinkaya004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No