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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04806087
Other study ID # 2019/10
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 18, 2019
Est. completion date September 30, 2020

Study information

Verified date March 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date September 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Audette I, Dumas JP, Côté 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Secondary 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. Baseline
Secondary 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. Baseline
Secondary 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. Within a 5-to-7-day period after the first assessment
Secondary 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. Within a 5-to-7-day period after the first assessment
Secondary 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. Within a 5-to-7-day period after the first assessment
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