Range of MotionNCT06537830
Validity And Reliability of Wearable Motion Sensors in Knee Joint Range of Motion Measurement
An observational study of Range of Motion and Knee, run by Halic University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Range of Motion, Knee
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2021to 15 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- being between the ages of 18-25
- volunteering to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Range of Motion, Knee
- Keywords
- Wearable motion sensors, MetamotionRL, IMUs
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start15 Dec 2021
- Primary completion30 Apr 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Range of MotionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melek Güneş Yavuzer, Prof., Study director, Halic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537830
- Sponsor's protocol ID
- Acetinkaya004
- Status last verified
- Aug 2024
- First submitted
- 28 Jul 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity And Reliability of Wearable Motion Sensors in Knee Joint Range of Motion Measurement
- ClinicalTrials.gov ID
- NCT06537830
- Acronym / sponsor ID
- Acetinkaya004
- Conditions
- Range of Motion, Knee
- Keywords
- Wearable motion sensors, MetamotionRL, IMUs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- being between the ages of 18-25
- volunteering to participate in the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digital goniometer measurement
Time frame: at baseline
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.
MetaMotionRLs measurement
Time frame: at baseline
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melek Güneş Yavuzer, Prof. study director
Halic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Range of Motion and Knee, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital goniometer measurement (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.