Forward Head PostureNCT04253821
Relationship Between Head Posture Muscles, Pulmonary Capacity and Functional Capacity: a Myotonometric Assessment
A study testing muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index in people with Forward Head Posture and Muscle Tone, run by Cagtay Maden at 1 site in Turkey (Türkiye).
Trial summary
Forward head posture (FHP) is known to have a large influence on respiratory function by weakening the respiratory muscles. This cross-sectional study is designed to examine the relationship between the tonus, stiffness, and elasticity of head posture muscles and pulmonary capacity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture, Muscle Tone, Muscle Stiffnes
- What is being tested?
- muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- the participants do not have any known pulmonary, systemic and muscular system disease and, any neurological symptoms and neck pain that affects daily living activities.
Who cannot join
- have headache and dizziness
- steroid use or muscle relaxants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between the Tonus, Stiffness, and Elasticity of Head Posture Muscles and Pulmonary Capacity and Functional Capacity: a Myotonometric Assessment
Forward head posture (FHP) is known to have a large influence on respiratory function by weakening the respiratory muscles. This cross-sectional study is designed to examine the relationship between the tonus, stiffness, and elasticity of head posture muscles and pulmonary capacity. Sixteen FHP individuals and seventeen NFHP individuals were evaluated. The muscle tonus, stiffness and elasticity of upper trapezius (UT), semispinalis capistis (SSC), pectoral muscles (PM) and sternocleidomastoideus muscles (SCM) were measured by using MyotonPro® device. Functional capacity was measured with six-minute walk test. Pulmonary function tests was evaluated with spirometer. The neck disability index (NDT) was applied. The forward head posture was determined by measurements of craniovertebral angle (CVA). Physical activity levels of participants were evaluated by Physical Activity Index (FIT).
- Being tested
- muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index
- Keywords
- forward head posture, muscle elasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability indexOther
The muscle tonus, stiffness and elasticity of upper trapezius (UT), semispinalis capistis (SSC), pectoral muscles (PM) and sternocleidomastoideus muscles (SCM) were measured by using MyotonPro® device. Functional capacity was measured with six-minute walk test. Pulmonary function tests was evaluated with spirometer. The neck disability index (NDT) was applied. The forward head posture was determined by measurements of craniovertebral angle (CVA). Physical activity levels of participants were evaluated by Physical Activity Index (FIT).
| Study group | Role | What they receive |
|---|---|---|
| Forward head posture | Active comparator | Not described Receives: Other: muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index |
| Non-Forward head posture | Active comparator | Not described Receives: Other: muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle tonus, stiffness and elasticity
The measurements of muscle tone, stiffness and elasticity were made by using MyotonPro® device. Participants were seated on the chair and hands were placed on the knee, UT, SSC and SCM muscles were measured in this position. The pectoralis major muscle was measured in the supine position.
Measured: 1 day
six-minute walk test.
Functional capacity was measured with six-minute walk test.
Measured: 1 day
Vital Capacity
Pulmonary function tests was evaluated with spirometer.It is the volume of air in the lungs that varies between full inspiration and maximum expiration.
Measured: 1 day
Forced Vital Capacity (FVC)
Pulmonary function tests was evaluated with spirometer.It is the volume of air that comes out with rapid and powerful exhalation following deep inspiratory. Healthy people can normally extract 80% of their lung volume in 6 seconds or less.
Measured: 1 day
Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function tests was evaluated with spirometer.It is the volume of air released in the first second from the beginning of the difficult vital capacity maneuver. In general, it gives information about the restriction in major airlines. FEV1 / FVC ratio decrease shows obstruction, FEV1 shows the severity of obstruction.
Measured: 1 day
Peak Expiratory Flow (PEF)
Pulmonary function tests was evaluated with spirometer.It is measured by the maximum exhalation maneuver following the maximum inspiration. It gives information about obstruction in large airways.
Measured: 1 day
The neck disability index
The neck disability index was applied. the total score is 50. As the test score rises, disability increases.0-4 score no disability, 5-14 mild disability, 15-24 moderate degree, 25-34 severe disability, 35 and above completely disabled
Measured: 1 day
Physical Activity Index
The FIT index was used to classify the individuals' physical activity levels. This research instrument used to classify and assign a score from 1 to 100 to a person's physical fitness level based on their frequency, intensity, and time engaged in physical fitness activities. The physical activity score was obtained by multiplying the frequency, intensity and time of the activity. According to the FIT score, the physical activity level is interpreted as 0-20 sedentary, 21-40 weak, 41-60 normal, 61-80 good and 81-100 very good.
Measured: 1 day
Forward head posture assessment
Forward head posture was assessed by a goniometric method which is accepted as a reliable method. Participants were assessed in a relaxed sitting position. To measure the craniovertebral angle (CVA) of FHP, the center of the goniometer is placed at the level of the orifice of the external ear with the fixed arm pointing vertically towards the ceiling and the moving arm against the subject's 7th neck bonee.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Jan 2020
- Primary completion1 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cagtay Maden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cagtay Maden, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253821
- Sponsor's protocol ID
- 2019/24
- Status last verified
- Oct 2023
- First submitted
- 27 Jan 2020
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Tonus, Stiffness, and Elasticity of Head Posture Muscles and Pulmonary Capacity and Functional Capacity: a Myotonometric Assessment
- ClinicalTrials.gov ID
- NCT04253821
- Acronym / sponsor ID
- 2019/24
- Keywords
- forward head posture, muscle elasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Cagtay MadenUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Forward head posture (FHP) is known to have a large influence on respiratory function by weakening the respiratory muscles. This cross-sectional study is designed to examine the relationship between the tonus, stiffness, and elasticity of head posture muscles and pulmonary capacity. Sixteen FHP individuals and seventeen NFHP individuals were evaluated. The muscle tonus, stiffness and elasticity of upper trapezius (UT), semispinalis capistis (SSC), pectoral muscles (PM) and sternocleidomastoideus muscles (SCM) were measured by using MyotonPro® device. Functional capacity was measured with six-minute walk test. Pulmonary function tests was evaluated with spirometer. The neck disability index (NDT) was applied. The forward head posture was determined by measurements of craniovertebral angle (CVA). Physical activity levels of participants were evaluated by Physical Activity Index (FIT).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Forward head posture | Active comparator | Other: muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index |
| Non-Forward head posture | Active comparator | Other: muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- the participants do not have any known pulmonary, systemic and muscular system disease and, any neurological symptoms and neck pain that affects daily living activities.
Key exclusion criteria (2 listed)
- have headache and dizziness
- steroid use or muscle relaxants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability indexThe muscle tonus, stiffness and elasticity of upper trapezius (UT), semispinalis capistis (SSC), pectoral muscles (PM) and sternocleidomastoideus muscles (SCM) were measured by using MyotonPro® device. Functional capacity was measured with six-minute walk test. Pulmonary function tests was evaluated with spirometer. The neck disability index (NDT) was applied. The forward head posture was determined by measurements of craniovertebral angle (CVA). Physical activity levels of participants were evaluated by Physical Activity Index (FIT). | Other | Forward head posture, Non-Forward head posture |
Primary outcome
muscle tonus, stiffness and elasticity
Time frame: 1 day
The measurements of muscle tone, stiffness and elasticity were made by using MyotonPro® device. Participants were seated on the chair and hands were placed on the knee, UT, SSC and SCM muscles were measured in this position. The pectoralis major muscle was measured in the supine position.
six-minute walk test.
Time frame: 1 day
Functional capacity was measured with six-minute walk test.
Vital Capacity
Time frame: 1 day
Pulmonary function tests was evaluated with spirometer.It is the volume of air in the lungs that varies between full inspiration and maximum expiration.
Forced Vital Capacity (FVC)
Time frame: 1 day
Pulmonary function tests was evaluated with spirometer.It is the volume of air that comes out with rapid and powerful exhalation following deep inspiratory. Healthy people can normally extract 80% of their lung volume in 6 seconds or less.
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: 1 day
Pulmonary function tests was evaluated with spirometer.It is the volume of air released in the first second from the beginning of the difficult vital capacity maneuver. In general, it gives information about the restriction in major airlines. FEV1 / FVC ratio decrease shows obstruction, FEV1 shows the severity of obstruction.
Peak Expiratory Flow (PEF)
Time frame: 1 day
Pulmonary function tests was evaluated with spirometer.It is measured by the maximum exhalation maneuver following the maximum inspiration. It gives information about obstruction in large airways.
The neck disability index
Time frame: 1 day
The neck disability index was applied. the total score is 50. As the test score rises, disability increases.0-4 score no disability, 5-14 mild disability, 15-24 moderate degree, 25-34 severe disability, 35 and above completely disabled
Physical Activity Index
Time frame: 1 day
The FIT index was used to classify the individuals' physical activity levels. This research instrument used to classify and assign a score from 1 to 100 to a person's physical fitness level based on their frequency, intensity, and time engaged in physical fitness activities. The physical activity score was obtained by multiplying the frequency, intensity and time of the activity. According to the FIT score, the physical activity level is interpreted as 0-20 sedentary, 21-40 weak, 41-60 normal, 61-80 good and 81-100 very good.
Forward head posture assessment
Time frame: 1 day
Forward head posture was assessed by a goniometric method which is accepted as a reliable method. Participants were assessed in a relaxed sitting position. To measure the craniovertebral angle (CVA) of FHP, the center of the goniometer is placed at the level of the orifice of the external ear with the fixed arm pointing vertically towards the ceiling and the moving arm against the subject's 7th neck bonee.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index in people with Forward Head Posture and Muscle Tone, run by Cagtay Maden at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle tonus, stiffness and elasticity (time frame: 1 day). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.