Impact of Craniovertebral Angle on Dizziness and Risk of Falling in Cervical Radiculopathy Patients

January 14, 2024 updated by: Sara Abdelrahman Elsayed Hassan Aboud, Cairo University

Impact of the Craniovertebral Angle on the Cervicogenic Dizziness and the Risk of Falling in Patients With Cervical Radiculopathy

-The goal of this observational study is to learn about the impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .The main question it aims to answer is: Is there an impact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy ? The participants will be undergone measuring the cranio-vertebral angle ,assessment of cervical proprioception and other tasks and questions through 3scales .

Researchers will compare between study group and control group to see if there isimpact of the changes in cranio-vertebral angle on the cervicogenic dizziness and the risk of falling in the patients with cervical radiculopathy .

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.

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.
Observational

Enrollment (Estimated)

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.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
    • Giza Governorate
      • Dokki, Giza Governorate, Egypt, 12612
        • Recruiting
        • Faculty of Physical Therapy labs at Cairo University
        • Contact:
        • Contact:
          • Faculty of Physical Therapy Labs at Cairo University

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

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will be enrolled in this study. Patients will be assigned into two groups (study and control groups) . The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ). Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA =more than 49°). Patients in group I were diagnosed as patients with chronic cervical radiculopathy with forward head posture (FHP) based on careful clinical evaluation by the neurologist . The patients will be recruited from the faculty of Physical Therapy, Cairo University, and private clinic in cairo .

Description

Inclusion Criteria:

  • The Patients will include if they have the following:

    1. Fifty patients with chronic cervical radiculopathy(degenerative type) from both sex will participate in the study (twenty five with forward head posture (FHP) , and twenty five without forward head posture (FHP) ).
    2. The duration of the disease (cervical radiculopathy)is more than 6 months.
    3. The age ranged from 35 to 50 years old.
    4. Mild to moderate neck pain on visual analogue scale .
    5. Pain and dizziness lasting for 3-6 months.

    6. subjective dizziness experienced in conjunction with cervical pain, movement, stiffness, or particular postures.

      Exclusion Criteria:

  • The Patients will exclude if they exhibit any of the following:

    1. Cervical myelopathy.
    2. Cervical myelo-radiculopathy.
    3. Acute cervical radiculopathy.
    4. Diabetic neuropathy.
    5. Previous cervical surgery.
    6. Cervical trauma.
    7. Deformities in the cervical spine .
    8. Rheumatoid arthritis.
    9. Any tumours and infection involving the cervical spine .
    10. Patients with a history of neuromuscular disorders.
    11. precise diagnosis of either central dizziness (due to cerebrovascular disorders related to the vertebrobasilar circulation, migraine, multiple sclerosis, tumours of the posterior fossa, neurodegenerative disorders, some drugs, and psychiatric disorders) or peripheral dizziness( due to a problem in the part of the inner ear that controls balance. These areas are called the vestibular labyrinth, or semicircular canals. The problem may also involve the vestibular nerve. This is the nerve between the inner ear and the brain stem).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
The Study group (GI)
The Study group (GI) will include twenty five patients with chronic cervical radiculopathy with forward head posture (FHP) (CVA=less than 49° ).
The Control group (GII)
The Control group (GII) will include twenty five patients with chronic cervical radiculopathy without forward head posture (FHP)( CVA = more than 49).

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
Craniovertebral angle (CVA)
Time Frame: 20 minutes
Taking photos from lateral view then craniovertebral angle measured by Kinovea software program.
20 minutes
Cervical joint position error .
Time Frame: 40 minutes
Cervical joint position error via the CROM device,through the neutral head repositioning test (NHR) and the target head repositioning test (THR).
40 minutes
Cervicogenic dizziness.
Time Frame: 10 minutes
Cervicogenic dizziness via score of Dizziness Handicap Inventory Questionnaire(DHI).
10 minutes
The risk of falling.
Time Frame: 20 minutes
The risk of falling assessed by Berg Balance Scale(BBS) .
20 minutes
The fear of falling.
Time Frame: 10 minutes
The fear of falling assessed by Fall Efficacy Scale-International(FES-I).
10 minutes

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.
Cairo 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 (Actual)

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.
September 4, 2023

Primary Completion (Estimated)

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.
January 29, 2024

Study Completion (Estimated)

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.
January 29, 2024

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 14, 2024

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 14, 2024

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 24, 2024

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 24, 2024

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 14, 2024

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, 2024

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.
  • P.T.REC/012/004743

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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