The Effects of Local Vibration and Cervical Stabilization Exercises Applied on Neck Muscles on Balance in Healthy Individuals

December 17, 2018 updated by: Ceyhun Turkmen, Hacettepe University

In healthy individuals, many postural musculoskeletal problems arise due to various reasons. The cervical region is the region where these problems are most common. The cervical region ranks second in the general population after the lumbal area of musculoskeletal system disorders and affects close to 70% of the general population.The most important causes of this posture disorder are; muscular performance and strength are inadequate, as well as decreased proprioception of the muscles, deterioration of the individual balance systems that result in individual visual or vestibular problems.

Exercise therapy is at the forefront of these methods, while a variety of methods are applied in the prevention and treatment of neck problems. Recent studies have focused on multifaceted treatments including exercises to improve strength, endurance and coordination of cervical muscles, proprioceptive training, relaxation exercises to prevent muscle tension, stabilization exercises and behavior modification. Cervical stabilization exercises are a frequently used exercise approach. Cervical stabilization exercises, which are different from ordinary exercises, are based on biomechanics, neurophysiology and physiotherapy research. The main objective of this method is; improve body awareness, maintain posture uniformity, improve strength, endurance, coordination and proprioception. Stabilization exercises also increase the strength and endurance of the postural and stabilizer muscles, improving stability control in the stabilized and non-stabilized positions.

Another method that contributes to the development of balance and proprioceptive sense is vibration application. Proprioception plays an important role in ensuring the coordination of movements. When the proprioception input is disturbed, both the position sense and the speed of movement may be affected. Muscle-tendon vibration is a noninvasive method that is often used in proprioception studies. It has been suggested that the vibration application are the enhancing effect of the proprioceptive. However, there is not enough research on this subject.

The purpose of this study is to determine whether the cervical stabilization exercises to be applied to the cervical region and the local vibration applied to the neck muscles are related to muscle performance, proprioception and balance and their superiority with each other.

Study Overview

Status

Status

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

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.

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 (Actual)

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.
16

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

14 years to 26 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Individuals who have not had neck pain in the last six months.

Exclusion Criteria:

  • Patients with atypical spinal cord anomalies, inflammatory or rheumatologic disorders, malignancy history, radiculopathy, myelopathy or other neurological disorders, vestibular disorders, and vertebral trauma history who underwent any surgical treatment for vertebral colonic at least 3 months before, was not included in the study.

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.
Active Comparator: Vibration Group
Local vibration on neck muscles
Device: Neck Muscle Vibration
Local vibration device applied on neck muscles for 8 weeks
Active Comparator: Stabilization Group
Cervical stabilization exercises on cervical region
Behavioral: Cervical Stabilization Exercises
Cervical stabilization exercises performed by healty individuals for 8 weeks
No Intervention: Control Group
Individuals performed only daily living activities

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
Sensory Organization Test
Time Frame: SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.
The sensory organization test. The sensory organization test (SOT) was developed to describe the contribution levels of the three basic systems of balance (visual, vestibular, somatosensory) to the general equilibrium. SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.
SOT was used to assess changes in visual, vestibular, and somatosensory balance of individuals at eighth week.

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
Head Shake Sensory Organization Test (HS-SOT)
Time Frame: HS-SOT was used to assess changes only vestibular balance of individuals at eighth week.
This test is applied in the second and fifth cases of the standard Sensory Organization Test, with eyes closed for events, with the task of shaking the head.
HS-SOT was used to assess changes only vestibular balance of individuals at eighth week.

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.
Hacettepe University

Publications and helpful links

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General Publications

Study record dates

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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 12, 2016

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.
November 15, 2016

Study Completion (Actual)

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 2, 2017

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).
February 27, 2018

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.
March 12, 2018

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.
March 13, 2018

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.
December 19, 2018

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.
December 17, 2018

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.
December 1, 2018

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.
  • GO 15/716-04

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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