The Effect Of Cervical Muscle Fatigue in Neck Proprioception and Postural Stability

June 16, 2020 updated by: Alaa Yousri Mahmoud Atia

The Effect of Cervical Muscle Fatigue on Neck Proprioception and Postural Stability

PURPOSE:

To investigate the effect of cervical muscle Fatigue on neck proprioception and postural stability during cervical flexion.

BACKGROUND:

Postural stability is the ability to maintain the body in equilibrium either at rest or in a steady state of motion . Muscle fatigue is the diminished response of muscle to repeated stimulus. Cervical proprioceptive inputs provide important somatosensory information influencing postural stability. Hence, the investigators performed this study to evaluate the effect of experimentally induced fatigue on general cervical musculature on postural stability .

HYPOTHESES:

This study will hypnotize that:

  1. Cervical flexor muscle fatigue will have a significant effect on neck proprioception
  2. Cervical muscle fatigue will have a significant effect on posture stability

RESEARCH QUESTION:

Will fatigue of cervical flexors have an effect on neck proprioception and postural stability?

Study Overview

Status

Status

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

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

the research methodology that will be used

Induction of fatigue using isometric neck flexor muscle endurance test (NET):

An isometric neck muscle endurance test (NME test) will be performed for the deep neck flexors (Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli) until exhaustion in all participants occurs. With the subject in hook lying position through CHIN RETRACTION AND HEAD ELEVATED FROM THE COUCH.

All the assessment measurements will be done before and just immediately after performing the cervical muscle fatigue then after 15 minutes of fatigue induction(fatigue recovery) A. Measurement of neck proprioception using cervical joint position error test via OVERHEAD LASER POINTER

B. Measurement of postural stability using :

  1. Biodex balance system(limit of stability) to measure postural stability
  2. Multi-Directional Reach Test

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 (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.
45

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
      • Cairo, Giza, Egypt, 00202
        • Recruiting
        • Ministry of health
        • Contact:

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 40 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Residents from certain town

Description

Inclusion Criteria:

  • having cervical range of motion 80 to 90 of flextion, 70 degree of extension, 20 to 45 degrees if lateral flextion, and 80 to 90 rotation to both sides.
  • having normaluscle test strength for cervical neck flexors according to group manual muscle test
  • body mass index ranging from 18.5 to 24.9 kg/m2

Exclusion Criteria:

  • any history of pathological truma to the cervical,thoracic or lumbar spine, upper extremity or rib cage.
  • surgical condition of the spine
  • having any orthopedic, musculoskeletal or neurological disorders around cervical region.
  • any vestibular impairment (e.g.vertigo)
  • spinal postural deformities as hyper kyphosis &scoliosis

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

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
Induction of fatigue using isometric neck flexor muscle endurance test (NET):
Time Frame: six months
a. An isometric neck muscle endurance test (NME test) will be performed for the deep neck flexors (Rectus Capitus Anterior, Rectus Capitus Lateralis, Longus Capitus, Longus Colli) until exhaustion in all participants occurs. with the subject in hook lying position through CHIN RETRACTION AND HEAD ELEVATED FROM THE COUCH.
six months

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
Measurement of neck proprioception using cervical joint position error test via OVERHEAD LASER POINTER
Time Frame: six months
: A laser pointer will be fixed to a headband or strap. Target paper will be typically 40 cm in diameter that contains concentric circles in 1 cm increments, divided into 4 quadrants intersecting at the zero.
six months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Multi-Directional Reach Test
Time Frame: six months
Multi-Directional Reach (MDRT) is an inexpensive screening tool to determine the limits of stability of individuals in 4 directions. It measure how far an individual can voluntarily reach, thereby shifting the COG to the limits of the BOS with the feet stationary. The MDRT is a valid and reliable clinical measure for limits of stability. The test can be used to assess human postural stability in different four direction as follow (Roberta 2001)
six months
Biodex Balance System for The postural stability test
Time Frame: six months
The postural stability test emphasized on subject's ability to maintain center of balance. The subject's score on this test will assess the deviations from center, thus a lower score is more desirable than a higher score. Platform stability could be varied during this test by selecting (more options) from the Postural Stability Testing screen. It was proved that trial time, number of trials, starting and ending platform stability, rest count-downs or bilateral test could be set (Tropp and Odenrick., 2011).
six months

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.
Alaa Yousri Mahmoud Atia

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.
March 31, 2019

Primary Completion (Actual)

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.
June 15, 2020

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.
July 20, 2020

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).
June 14, 2019

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.
June 24, 2019

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.
June 26, 2019

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.
June 18, 2020

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.
June 16, 2020

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.
June 1, 2020

More Information

Terms related to this study

Keywords

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/012/002299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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