NCT04806087

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 14, 2021

Last Update Submit

March 18, 2021

Conditions

ProprioceptionPosition Sense

Keywords

reliabilityvaliditycervicalproprioceptionrehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Frontal Plane Target Platform Measurement with AOS PropPoint® Device

    Baseline

  • Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)

    Baseline

  • Horizontal Plane Target Platform Measurement with AOS PropPoint® Device

    Within a 5-to-7-day period after the first assessment

  • Frontal Plane Target Platform Measurement with AOS PropPoint® Device

    Within a 5-to-7-day period after the first assessment

  • Cervical Proprioception assesment with Cervical Range of Motion Device (CROM)

    Within a 5-to-7-day period after the first assessment

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample consist of volunteer, healthy participants.

You may qualify if:

  • age 18 to 35 years
  • bilateral cervical rotation of 30 degrees and above
  • being a volunteer.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34740, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 2009044BACKGROUND

  • 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.

    PMID: 18514016BACKGROUND

  • 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.

    PMID: 23810427BACKGROUND

  • 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.

    PMID: 20436238BACKGROUND

Study Officials

  • Aygül Köseoğlu, PT

    Bahçeşehir University

    STUDY CHAIR

  • Ebru K Mutlu

    İstanbul University- Cerrahpasa

    PRINCIPAL INVESTIGATOR

  • Dilber Çoskunsu

    Bahçeşehir University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 19, 2021

Study Start

October 18, 2019

Primary Completion

January 30, 2020

Study Completion

September 30, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

TU(1)