- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04806087
A New Method To Measure Cervical Proprioception
Validity And Reliability Of A New Method To Measure Cervical Proprioception
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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İstanbul, Turkey, 34740
- Istanbul University-Cerrahpasa
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- age 18 to 35 years
- bilateral cervical rotation of 30 degrees and above
- being a volunteer.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frontal Plane Target Platform Measurement with AOS PropPoint® Device
Time Frame: Baseline
|
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.
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Baseline
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Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)
Time Frame: Baseline
|
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.
|
Baseline
|
|
Horizontal Plane Target Platform Measurement with AOS PropPoint® Device
Time Frame: Within a 5-to-7-day period after the first assessment
|
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.
|
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
|
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.
|
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
|
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.
|
Within a 5-to-7-day period after the first assessment
|
Collaborators and Investigators
Investigators
- Study Chair: Aygül Köseoğlu, PT, Bahçeşehir University
- Principal Investigator: Ebru K Mutlu, Istanbul University- Cerrahpasa
- Study Director: Dilber Çoskunsu, Bahçeşehir University
Publications and helpful links
General 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.
- Roren 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.
- Chen 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.
- Audette 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019/10
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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