Effect of Stabilization Exercises in Individuals With Non-Specific Chronic Neck Pain.

October 12, 2023 updated by: Hatice AYAN, Izmir Katip Celebi University

The Effect of Different Stabilization Exercises Based on Telerehabilitation on Gait, Balance, Functionality and Depression in Individuals With Non-Specific Chronic Neck Pain

In this study, the effects of an 8-week telerehabilitation-based stabilization training in persons with chronic non-specific neck pain will be investigated.

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.

Detailed Description

The aim of the study is to investigate the effects of different telerehabilitation-based stabilization exercises on gait, balance, pain, functionality and depression in individuals with non-specific neck pain. The population of the study will consist of 40 individuals with chronic neck pain, who are followed up with the diagnosis of chronic non-specific neck pain in the Department of Neurosurgery of Dokuz Eylul University Faculty of Medicine. The socio-demographic characteristics of the participants will be recorded through mutual interviews, 'BTS G-Walk' device for walking, 'Biodex Balance' device for balance, Neck Disability Index for disability assessment, Visual Analog Scale (VAS) for pain severity, the Beck Depression Inventory will be used for depression. All participants will walk to the length of a 10 m walkway and back to the start point with the BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device to assess spatiotemporal gait parameters. Individuals will walk first in a normal walking pattern and then in a fast walking pattern. Biodex Stability System will be used for balance measurement. The exercises will be taught to the participants face-to-face once in the first session, within the framework of social distance and hygiene rules, and then they will have exercise sessions by mutual videoconference method via the Zoom program for 8 weeks. Patients will be randomly divided into two groups. Cervical stabilization and scapular stabilization training will be given to the first group, and cervical stabilization and core stabilization training will be given to the second group. The effects of these two different telerehabilitation-based exercise methods will be compared.

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.
41

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

Contacts and Locations

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

Study Locations

  • Turkey
      • Izmir, Turkey
        • School of Physical Therapy and Rehabilitation, Dokuz Eylül 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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Having non-specific neck pain for at least 3 months
  • Having a Neck Disability Index (BDI) score of 10 and above,

Exclusion Criteria:

  • Receiving physiotherapy for neck pain in the last 6 months
  • Having speech and comprehension problems,
  • Those who have undergone neck surgery
  • Those with sensory loss
  • Those diagnosed with orthopedic, neurological or vestibular disease
  • Those with a history of trauma ( wiplash)
  • Cases diagnosed with cancer, osteoporosis or treated will not be 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: None (Open Label)

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: Cervical and scapular stabilization group
In this arm cervical and scapular stabilization exercises will be applied based on the telerehabilitation method via videoconference for 8 weeks, one day a week , 45-60 minutes for each session.
Other: Telerehabilitation-based cervical and scapular stabilization exercises
Telerehabilitation based cervical and scapular stabilization exercises will be applied via videoconference method for 8 weeks, one day a week , 45-60 minutes for each session.
Experimental: Cervical and core stabilization group
In this arm cervical and core stabilization exercises will be applied based on the telerehabilitation method via videoconference for 8 weeks, one day a week , 45-60 minutes for each session.
Other: Telerehabilitation-based cervical and core stabilization exercises
Telerehabilitation based cervical and core stabilization exercises will be applied via videoconference method for 8 weeks, one day a week , 45-60 minutes for each session.

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
Speed
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess gait speed (m/sec) during usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).
Change from Baseline at 8 weeks
Cadence
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess cadence (steps/min) during the usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).
Change from Baseline at 8 weeks
Stride length
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess stride length (m) during the usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).
Change from Baseline at 8 weeks
Step lenght
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess step length (% stride length) during in usual walking condition and fast walking condition through a Bluetooth®3.0 connection (G-Studio®software).
Change from Baseline at 8 weeks
Gait Symmetry
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess gait symmetry. Gait symmetry index of the right and left sides are obtained during walking. The score is calculated by the device as a percentage score out of 100. The higher score indicates more symmetrical gait.
Change from Baseline at 8 weeks
Pelvic angles
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess pelvic movements (tilt (°), obliquity(°), rotation(°)) during gait through a Bluetooth®3.0 connection (G-Studio®software). The device provides the data for these pelvic angles in one single report.
Change from Baseline at 8 weeks
Pelvic symmetry
Time Frame: Change from Baseline at 8 weeks
The BTS G-Walk (BTS Bioengineering S.p.A., GarbagnateMilanese, Italy), a wearable sensor device, will be used to assess pelvic symmetry (%) during gait through a Bluetooth®3.0 connection (G-Studio®software). The score is calculated by the device as a percentage score out of 100. The higher score indicates more pelvic symmetry.
Change from Baseline at 8 weeks
Postural stability
Time Frame: Change from Baseline at 8 weeks
A computerized test of the Biodex Balance System will be used to assess postural stability. Subjects will stand on the platform and try to maintain their stability while trying to control their center of pressure which is shown as a point on the screen. The postural stability test assesses the patient's ability to control static balance on a stable platform. The test protocol is performed for 20 seconds with 3 trials. The mean value of the trials is taken as a score. Higher stability index score indicates poor balance and stability.
Change from Baseline at 8 weeks
Limits of stability
Time Frame: Change from Baseline at 8 weeks
A computerized test of limits of stability will be performed using Biodex Balance System®. Subjects will stand on a stable platform and try to maintain their balance while trying to reach in different directions spot that is shown on the screen. The test results present scores for all directions. Higher scores show better performance (0= worst performance; 100= perfect performance).
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
Neck Disability Index
Time Frame: Change from Baseline at 8 weeks
Neck Disability Index will be used to evaluate the effects of neck pain on functional disability.
Change from Baseline at 8 weeks
Visual Analog Scale (VAS)
Time Frame: Change from Baseline at 8 weeks
It consists of a 10 cm horizontal or vertically positioned line on the page. The number '0', which is the starting point on this line, represents the patient's no pain, and the number '10' represents the worst pain experienced by the patient.
Change from Baseline at 8 weeks
Beck Depression Inventory
Time Frame: Change from Baseline at 8 weeks
It is designed to measure the severity of depression, to assess changes with treatment, and to identify the disease.
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.
Izmir Katip Celebi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dokuz Eylul University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hatice Ayan, MSc, Izmir Katip Celebi 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.
May 11, 2022

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.
August 30, 2022

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.
October 1, 2022

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).
April 26, 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.
May 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.
May 11, 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.
October 16, 2023

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.
October 12, 2023

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.
October 1, 2023

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.
  • GOA-5309

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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