ProprioceptionNCT04806087
A New Method To Measure Cervical Proprioception
An observational study of Proprioception and Position Sense, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
To evaluate cervical proprioception (CP), frontal plane target platforms defined Revel technique measurement commonly used as an alternative to the Cervical Range of Motion (CROM) device in laser measurements for the head repositioning accuracy (HRA) test. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Proprioception, Position Sense
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2019to 30 Sep 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The sample consist of volunteer, healthy participants.
Who may be able to join
- age 18 to 35 years
- bilateral cervical rotation of 30 degrees and above
- being a volunteer.
Who cannot join
- all kinds of orthopedic and neurological problems that might cause head, eye and neck movement limitation; having a pacemaker, platinum, dental braces, etc., which might affect the magnetic field; and the presence of epilepsy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, 34740
About this study
Official title: Validity And Reliability Of A New Method To Measure Cervical Proprioception
To evaluate cervical proprioception (CP), frontal plane target platforms defined Revel technique measurement commonly used as an alternative to the Cervical Range of Motion (CROM) device in laser measurements for the head repositioning accuracy (HRA) test. However, when evaluating CP, the plane where the movement of the atlanto-axial joint takes place is the horizontal plane. Therefore, the investigators aimed to investigate the validity and reliability of CP measurements conducted via AOS PropPoint® device on the horizontal and frontal platforms, and the investigators hypothesized that horizontal platform measurement is more reliable and valid than frontal plane measurement.
Read the detailed description
It has been reported in a number of studies that methods utilizing laser are practical, easy, portable, and inexpensive in clinical use, a standardized and branded laser apparatus and system have not been identified. This has caused problems about whether the laser equipment used in the literature is valid and reliable in the evaluation of cervical proprioception (CP). Besides, the head repositioning accuracy (HRA) test, which was designed before for CP assessment and standardized with trigonometric equations, carries out measurements in the frontal plane. In addition, cervical rotation in the atlanto-axial joint occurs in the horizontal plane. Therefore, the investigators presume that evaluating the biomechanical motion occurring in the horizontal plane and transferring it directly to the horizontal plane will be more practical and reliable for practitioners.
The subjects' HRA values were measured through AOS ProPoint® device in the horizontal and frontal platforms and also through the CROM device. Each measurement was repeated bilaterally three times, and they were averaged. To validate the measurement method, a comparison between the CROM device used as the gold standard and the measurement values was made. Test-retest and inter-rater reliability scores were calculated to evaluate the reliability of the horizontal measurement method.
- Conditions
- Proprioception, Position Sense
- Keywords
- reliability, validity, cervical, proprioception, rehabilitation
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal Plane Target Platform Measurement with AOS PropPoint® Device
AOS PropPoint® is a practical, easy-to-use and low-cost device designed by physiotherapists to evaluate and improve the proprioceptive senses of various joints in the body. The fabric used to attach the laser apparatus to the head is made of a special veltec fabric. The laser pointer was placed at the center of the participants' atlanto-axial joint. The laser cursor was positioned at an angle of approximately 45° with the ground and projected onto a fixed semicircular horizontal target platform drawn with intervals of one degree. It was noted that the NHP and the 0° (zero point of the horizontal plane on the ground correspond to each other. The HRA measurement of AOS PropPoint® device on the horizontal platform was made simultaneously with the CROM. The deviation of the laser pointer from 0° (zero point) on the horizontal platform was recorded.
Measured: Baseline
Secondary outcomes (5)
Frontal Plane Target Platform Measurement with AOS PropPoint® Device
Target board was improved based on the formula tang^(-1) [error distance/90 cm]. The readings was accurate to ±0.5. We also used a target platform board with a diameter of 40 cm and graded at 1 cm intervals. The laser cursor was fixed with the help of veltec fabric in the center of the frontal bone of the volunteers. The subjects were seated 90 cm away from the frontal plane for the HRA test. When the volunteers felt that they were coming back to the starting point, the amount of deviation from the starting point was recorded by asking them to give a signal by simply extending their right index finger slightly, without opening their eyes.
Measured: Baseline
Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)
The CROM device has been proven to be a reliable and valid tool for HRA tests. The volunteers were seated in a chair without back support with their knees and hip joints positioned at 90 degrees, and their left shoulders pointing to the north of the room, where the measurement was made. They were also asked to wear magnetic collars so that their left shoulders always pointed north. A subject was blindfolded and seated on a chair with their head in the neutral head position (NHP), and was asked to relocate their head on the trunk as accurately as possible after cervical rotations of 30 degrees to the left and right sides. Three trials were carried out after a right head rotation and another three after a left head rotation and they were averaged for each side. The accuracy of head repositioning was measured through the absolute value of the constant error. Randomization was achieved by randomizing the measurements starting from the right or left side.
Measured: Baseline
Horizontal Plane Target Platform Measurement with AOS PropPoint® Device
AOS PropPoint® is a practical, easy-to-use and low-cost device designed by physiotherapists to evaluate and improve the proprioceptive senses of various joints in the body. The fabric used to attach the laser apparatus to the head is made of a special veltec fabric. The laser pointer was placed at the center of the participants' atlanto-axial joint. The laser cursor was positioned at an angle of approximately 45° with the ground and projected onto a fixed semicircular horizontal target platform drawn with intervals of one degree. It was noted that the NHP and the 0° (zero point of the horizontal plane on the ground correspond to each other. The HRA measurement of AOS PropPoint® device on the horizontal platform was made simultaneously with the CROM. The deviation of the laser pointer from 0° (zero point) on the horizontal platform was recorded.
Measured: Within a 5-to-7-day period after the first assessment
Frontal Plane Target Platform Measurement with AOS PropPoint® Device
Target board was improved based on the formula tang^(-1) [error distance/90 cm]. The readings was accurate to ±0.5. We also used a target platform board with a diameter of 40 cm and graded at 1 cm intervals. The laser cursor was fixed with the help of veltec fabric in the center of the frontal bone of the volunteers. The subjects were seated 90 cm away from the frontal plane for the HRA test. When the volunteers felt that they were coming back to the starting point, the amount of deviation from the starting point was recorded by asking them to give a signal by simply extending their right index finger slightly, without opening their eye.
Measured: Within a 5-to-7-day period after the first assessment
Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)
The CROM device has been proven to be a reliable and valid tool for HRA tests. The volunteers were seated in a chair without back support with their knees and hip joints positioned at 90 degrees, and their left shoulders pointing to the north of the room, where the measurement was made. They were also asked to wear magnetic collars so that their left shoulders always pointed north. A subject was blindfolded and seated on a chair with their head in the neutral head position (NHP), and was asked to relocate their head on the trunk as accurately as possible after cervical rotations of 30 degrees to the left and right sides. Three trials were carried out after a right head rotation and another three after a left head rotation and they were averaged for each side. The accuracy of head repositioning was measured through the absolute value of the constant error. Randomization was achieved by randomizing the measurements starting from the right or left side.
Measured: Within a 5-to-7-day period after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start18 Oct 2019
- Primary completion30 Jan 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ProprioceptionStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa
- Investigators
- Aygül Köseoğlu, PT, Study chair, Bahçeşehir UniversityEbru K Mutlu, Principal investigator, İstanbul University- CerrahpasaDilber Çoskunsu, Study director, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806087
- Sponsor's protocol ID
- 2019/10
- Status last verified
- Mar 2021
- First submitted
- 14 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.
PubMed 2009044Roren A, Mayoux-Benhamou MA, Fayad F, Poiraudeau S, Lantz D, Revel M. Comparison of visual and ultrasound based techniques to measure head repositioning in healthy and neck-pain subjects. Man Ther. 2009 Jun;14(3):270-7. doi: 10.1016/j.math.2008.03.002. Epub 2008 Jun 2.
PubMed 18514016Chen X, Treleaven J. The effect of neck torsion on joint position error in subjects with chronic neck pain. Man Ther. 2013 Dec;18(6):562-7. doi: 10.1016/j.math.2013.05.015. Epub 2013 Jun 26.
PubMed 23810427Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
PubMed 20436238
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity And Reliability Of A New Method To Measure Cervical Proprioception
- ClinicalTrials.gov ID
- NCT04806087
- Acronym / sponsor ID
- 2019/10
- Conditions
- Proprioception, Position Sense
- Keywords
- reliability, validity, cervical, proprioception, rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 19 Mar 2021 (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.
To evaluate cervical proprioception (CP), frontal plane target platforms defined Revel technique measurement commonly used as an alternative to the Cervical Range of Motion (CROM) device in laser measurements for the head repositioning accuracy (HRA) test. However, when evaluating CP, the plane where the movement of the atlanto-axial joint takes place is the horizontal plane. Therefore, the investigators aimed to investigate the validity and reliability of CP measurements conducted via AOS PropPoint® device on the horizontal and frontal platforms, and the investigators hypothesized that horizontal platform measurement is more reliable and valid than frontal plane measurement.
Detailed description
It has been reported in a number of studies that methods utilizing laser are practical, easy, portable, and inexpensive in clinical use, a standardized and branded laser apparatus and system have not been identified. This has caused problems about whether the laser equipment used in the literature is valid and reliable in the evaluation of cervical proprioception (CP). Besides, the head repositioning accuracy (HRA) test, which was designed before for CP assessment and standardized with trigonometric equations, carries out measurements in the frontal plane. In addition, cervical rotation in the atlanto-axial joint occurs in the horizontal plane. Therefore, the investigators presume that evaluating the biomechanical motion occurring in the horizontal plane and transferring it directly to the horizontal plane will be more practical and reliable for practitioners.
The subjects' HRA values were measured through AOS ProPoint® device in the horizontal and frontal platforms and also through the CROM device. Each measurement was repeated bilaterally three times, and they were averaged. To validate the measurement method, a comparison between the CROM device used as the gold standard and the measurement values was made. Test-retest and inter-rater reliability scores were calculated to evaluate the reliability of the horizontal measurement method.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The sample consist of volunteer, healthy participants.
Key inclusion criteria (3 listed)
- age 18 to 35 years
- bilateral cervical rotation of 30 degrees and above
- being a volunteer.
Key exclusion criteria (1 listed)
- all kinds of orthopedic and neurological problems that might cause head, eye and neck movement limitation; having a pacemaker, platinum, dental braces, etc., which might affect the magnetic field; and the presence of epilepsy.
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
Horizontal Plane Target Platform Measurement with AOS PropPoint® Device
Time frame: Baseline
AOS PropPoint® is a practical, easy-to-use and low-cost device designed by physiotherapists to evaluate and improve the proprioceptive senses of various joints in the body. The fabric used to attach the laser apparatus to the head is made of a special veltec fabric. The laser pointer was placed at the center of the participants' atlanto-axial joint. The laser cursor was positioned at an angle of approximately 45° with the ground and projected onto a fixed semicircular horizontal target platform drawn with intervals of one degree. It was noted that the NHP and the 0° (zero point of the horizontal plane on the ground correspond to each other. The HRA measurement of AOS PropPoint® device on the horizontal platform was made simultaneously with the CROM. The deviation of the laser pointer from 0° (zero point) on the horizontal platform was recorded.
5 secondary outcomes
Frontal Plane Target Platform Measurement with AOS PropPoint® Device
Time frame: Baseline
Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)
Time frame: Baseline
Horizontal Plane Target Platform Measurement with AOS PropPoint® Device
Time frame: Within a 5-to-7-day period after the first assessment
Frontal Plane Target Platform Measurement with AOS PropPoint® Device
Time frame: Within a 5-to-7-day period after the first assessment
Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)
Time frame: Within a 5-to-7-day period after the first assessment
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 22 Mar 2021.
- Background: PubMed 2009044Revel M, Andre-Deshays C, Minguet M. Cervicocephalic kinesthetic sensibility in patients with cervical pain. Arch Phys Med Rehabil. 1991 Apr;72(5):288-91.
- Background: PubMed 18514016Roren A, Mayoux-Benhamou MA, Fayad F, Poiraudeau S, Lantz D, Revel M. Comparison of visual and ultrasound based techniques to measure head repositioning in healthy and neck-pain subjects. Man Ther. 2009 Jun;14(3):270-7. doi: 10.1016/j.math.2008.03.002. Epub 2008 Jun 2.
- Background: PubMed 23810427Chen X, Treleaven J. The effect of neck torsion on joint position error in subjects with chronic neck pain. Man Ther. 2013 Dec;18(6):562-7. doi: 10.1016/j.math.2013.05.015. Epub 2013 Jun 26.
- Background: PubMed 20436238Audette I, Dumas JP, Cote JN, De Serres SJ. Validity and between-day reliability of the cervical range of motion (CROM) device. J Orthop Sports Phys Ther. 2010 May;40(5):318-23. doi: 10.2519/jospt.2010.3180.
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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.
Aygül Köseoğlu, PT study chair
Bahçeşehir University
Ebru K Mutlu principal investigator
İstanbul University- Cerrahpasa
Dilber Çoskunsu study director
Bahçeşehir 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 Proprioception and Position Sense, run by Istanbul University - Cerrahpasa 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 3 inclusion and 1 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 22 Mar 2021. 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?
Horizontal Plane Target Platform Measurement with AOS PropPoint® Device (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04806087, which also lists 4 linked publications.
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 22 Mar 2021.