Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT01186718
Status:
COMPLETED
Last Update Posted:
2011-11-29
First Post:
2010-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Interexaminer Reliability, Outcomes for Manipulation of Cervical Dysfunction, 3-D Kinematics
Sponsor:
Michigan State University
Organization:
Study Overview
Official Title:
Three-dimensional Study of Cervical Kinematics
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this project is to quantify 3-dimensional (3-D) cervical motion pattern changes that result from osteopathic manipulation treatment (OMT) in an experimental subject group diagnosed with somatic dysfunction. The kinematic data will include the entire 3-D motion trajectories of the head, resulting in range of motion (ROM) and angular data for the primary and secondary motions.
Detailed Description:
Our primary hypothesis is that kinematic changes will be detected after OMT for motions in the primary direction of the passive diagnostic test motions (cervical side-bending right and left), as well as angular rotations (deviations) occurring around these motions. Our secondary hypothesis is that examination of the kinematic data will provide objective inter- and intra-examiner data to assess similarities/differences occurring during the passive clinical exam before and after OMT. Lastly, we hypothesize that significant differences in the kinematic patterns will result between the two subject groups.
This experiment is designed for the following clinical and biomechanical observations:
* comparisons of diagnostic data between three osteopathic physicians,
* comparisons of within-subject kinematic profiles pre- and post-treatment,
* inter-examiner comparisons of kinematic motion paths occurring during diagnostic motions,
* evaluate kinematic patterns between the two subject groups, and assess between group similarities/differences,
* evaluate diagnostic and kinematic data relative to VAS, cervical disability, health status information, and SNF,
* re-classify aspects of the kinematic data using a cluster (statistical) analysis procedure to compare with initial and secondary physician diagnostic data, and
* to assess the stability of changes made by the OMT procedures and the kinematic response three days post-treatment.
This experiment is designed for the following clinical and biomechanical observations:
* comparisons of diagnostic data between three osteopathic physicians,
* comparisons of within-subject kinematic profiles pre- and post-treatment,
* inter-examiner comparisons of kinematic motion paths occurring during diagnostic motions,
* evaluate kinematic patterns between the two subject groups, and assess between group similarities/differences,
* evaluate diagnostic and kinematic data relative to VAS, cervical disability, health status information, and SNF,
* re-classify aspects of the kinematic data using a cluster (statistical) analysis procedure to compare with initial and secondary physician diagnostic data, and
* to assess the stability of changes made by the OMT procedures and the kinematic response three days post-treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: