The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine

January 10, 2022 updated by: seyda toprak celenay, Ankara Yildirim Beyazıt University
The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cervical muscles are adversely affected in individuals with migraine. It is important to investigate the effects of cervical muscle training in these individuals. Telerehabilitation applications have been used frequently in many patients in recent years. It is necessary to examine the effects of cervical stabilization exercises applied with telerehabilitation in individuals with migraine.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being between the ages of 18-55,
  • To be diagnosed with migraine by a neurologist according to International Headache Society criteria,
  • Having at least 3 migraine attacks per month,
  • Volunteering to participate in the study,
  • Having the opportunity to access devices such as computers, phones and tablets with internet connection,
  • Not having any problems that prevent cooperation and understanding

Exclusion Criteria:

  • Having other accompanying headache types,
  • Being pregnant,
  • Being in the breastfeeding period,
  • Having a history of trauma, fracture or surgery in the craniocervical region,
  • Presence of concomitant neurological and/or inflammatory rheumatic disease
  • Presence of serious psychiatric problems,
  • History of malignancy,
  • Changes in medical treatment during the study period,
  • Receiving physiotherapy for the cervical region in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise group
Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks
Other: Cervical Stabilization Exercise
Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks
Active Comparator: Standard treatment group
Standard treatment group will be given preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks.
Other: Standard treatment
standard treatment will include preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The characteristic of the migraine
Time Frame: change from baseline at 8 weeks
The characteristic of the migraine will be evaluated with the "Headache Diary".
change from baseline at 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cervical range of motion
Time Frame: change from baseline at 8 weeks
Cervical range of motion was evaluated using the goniometer
change from baseline at 8 weeks
Upper cervical region movements
Time Frame: change from baseline at 8 weeks
Upper cervical region movements will be evaluated with a Cervical Range of Motion device
change from baseline at 8 weeks
Performance of the deep neck flexor muscles
Time Frame: change from baseline at 8 weeks
Performance of the deep neck flexor muscles will be evaluated with a Stabilizer Pressure Biofeedback Unit
change from baseline at 8 weeks
Cranio-vertebral angle
Time Frame: change from baseline at 8 weeks
The cranio-vertebral angle will be measured with a goniometer
change from baseline at 8 weeks
Disability Status
Time Frame: change from baseline at 8 weeks
The Turkish version of Migraine Disability Assessment Scale will be used to determine the disability status in daily activities of individuals due to migraine
change from baseline at 8 weeks
Sleep quality
Time Frame: change from baseline at 8 weeks
Sleep quality will be evaluated with the Turkish version of Jenkins Sleep Scale
change from baseline at 8 weeks
Life quality
Time Frame: change from baseline at 8 weeks
Life quality will be evaluated with the Turkish version of Headache Impact Test
change from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/01/8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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