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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Telerehabilitation-based cervical and scapular stabilization exercises
Telerehabilitation-based cervical and core stabilization exercises
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Chronic Non-Spesific Neck Pain, Telerehabilitation, Gait, Balance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Physical Therapy and Rehabilitation, Dokuz Eylül University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cervical and scapular stabilization group

Cervical and core stabilization group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Speed
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).
Cadence
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).
Stride length
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).
Step lenght
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).
Gait Symmetry
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.
Pelvic angles
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.
Pelvic symmetry
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.
Postural stability
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.
Limits of stability
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).

Secondary Outcome Measures

Neck Disability Index
Neck Disability Index will be used to evaluate the effects of neck pain on functional disability.
Visual Analog Scale (VAS)
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.
Beck Depression Inventory
It is designed to measure the severity of depression, to assess changes with treatment, and to identify the disease.

Full Information

First Posted
April 26, 2022
Last Updated
October 12, 2023
Sponsor
Izmir Katip Celebi University
Collaborators
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05369260
Brief Title
Effect of Stabilization Exercises in Individuals With Non-Specific Chronic Neck Pain.
Official Title
The Effect of Different Stabilization Exercises Based on Telerehabilitation on Gait, Balance, Functionality and Depression in Individuals With Non-Specific Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
Collaborators
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Chronic Non-Spesific Neck Pain, Telerehabilitation, Gait, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cervical and scapular stabilization group
Arm Type
Experimental
Arm Description
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.
Arm Title
Cervical and core stabilization group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation-based cervical and scapular stabilization exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Telerehabilitation-based cervical and core stabilization exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Speed
Description
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).
Time Frame
Change from Baseline at 8 weeks
Title
Cadence
Description
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).
Time Frame
Change from Baseline at 8 weeks
Title
Stride length
Description
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).
Time Frame
Change from Baseline at 8 weeks
Title
Step lenght
Description
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).
Time Frame
Change from Baseline at 8 weeks
Title
Gait Symmetry
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Pelvic angles
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Pelvic symmetry
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Postural stability
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Limits of stability
Description
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).
Time Frame
Change from Baseline at 8 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
Neck Disability Index will be used to evaluate the effects of neck pain on functional disability.
Time Frame
Change from Baseline at 8 weeks
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
Change from Baseline at 8 weeks
Title
Beck Depression Inventory
Description
It is designed to measure the severity of depression, to assess changes with treatment, and to identify the disease.
Time Frame
Change from Baseline at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatice Ayan, MSc
Organizational Affiliation
Izmir Katip Celebi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
City
Izmir
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

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

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