A New Method To Measure Cervical Proprioception

Sponsor
Istanbul University-Cerrahpasa (Other)
Overall Status
Completed
CT.gov ID
NCT04806087
Collaborator
(none)
86
1
11.4
7.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    86 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Validity And Reliability Of A New Method To Measure Cervical Proprioception
    Actual Study Start Date :
    Oct 18, 2019
    Actual Primary Completion Date :
    Jan 30, 2020
    Actual Study Completion Date :
    Sep 30, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Horizontal Plane Target Platform Measurement with AOS PropPoint® Device [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.

    Secondary Outcome Measures

    1. Frontal Plane Target Platform Measurement with AOS PropPoint® Device [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.

    2. Cervical Proprioception assesment with Cervical Range of Motion Device (CROM) [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.

    3. Horizontal Plane Target Platform Measurement with AOS PropPoint® Device [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.

    4. Frontal Plane Target Platform Measurement with AOS PropPoint® Device [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.

    5. Cervical Proprioception assesment with Cervical Range of Motion Device (CROM) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istanbul University-Cerrahpasa İstanbul Turkey 34740

    Sponsors and Collaborators

    • Istanbul University-Cerrahpasa

    Investigators

    • Study Chair: Aygül Köseoğlu, PT, Bahçeşehir University
    • Principal Investigator: Ebru K Mutlu, İstanbul University- Cerrahpasa
    • Study Director: Dilber Çoskunsu, Bahçeşehir University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ebru Kaya Mutlu, PT, Assoc. Prof. Dr., Istanbul University-Cerrahpasa
    ClinicalTrials.gov Identifier:
    NCT04806087
    Other Study ID Numbers:
    • 2019/10
    First Posted:
    Mar 19, 2021
    Last Update Posted:
    Mar 22, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ebru Kaya Mutlu, PT, Assoc. Prof. Dr., Istanbul University-Cerrahpasa

    Study Results

    No Results Posted as of Mar 22, 2021