The Effects of a Specific Exercise Program on Subjects Wi... | NCT05500378

Studies
The Effects of a Specific Exercise Program on Subjects With Cervicogenic Headache

NCT05500378

Sponsor

Florida Gulf Coast University

Status

Terminated

Last Update Posted

Aug 7, 2025Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Cervicogenic Headache

Interventions

Head extension and rotation movement

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not enough subjects

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jul 1, 2025Actual

Completion Date

Jul 1, 2025Actual

First Submitted Date

Aug 10, 2022

First Submission Date that Met QC Criteria

Aug 12, 2022

First Posted Date

Aug 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2025

Last Update Posted Date

Aug 7, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study explores with the use of MSK Ultrasound imaging if the obliquus capitis minor and the rectus capitis major can be contracted with specific exercises.

Detailed Description

This study explores if a subject with the neck in full maximal flexion is able to selective contract the the obliquus capitis minor and the rectus capitis major by head extension and rotation while maintaining the spine position. MSK Ultrasound imaging will be used to measure changes both in length and width.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
neck extension group	Other	Neck extension group	Other: Head extension and rotation movement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Head extension and rotation movement	Other	Active exercise of the head	neck extension group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MSK US image	Assessment of change in width and length of target muscles	The change in muscle length and diameter will be measured during head movement

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No history of surgery, No current neck pain, Being able to move the neck actively, being able to read English, between ages 18-65

Exclusion Criteria:

Neck pain, History of surgery, unable to move the head into extension, outside age requirements, unable to read English

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rob Sillevis, phD	Florida Gulf Coast University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Florida Gulf Coast University		Fort Myers	Florida	33965	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051298	Post-Traumatic Headache
D009043	Motor Activity

Ancestor Terms

ID	Term
D051271	Headache Disorders, Secondary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided