NCT04253821

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

January 27, 2020

Last Update Submit

October 17, 2023

Conditions

Forward Head PostureMuscle ToneMuscle StiffnesMuscle ElastictyVital Capacity

Keywords

forward head posturemuscle elasticity

Outcome Measures

Primary Outcomes (9)

  • 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.

    1 day

  • six-minute walk test.

    Functional capacity was measured with six-minute walk test.

    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.

    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.

    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.

    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.

    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

    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.

    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.

    1 day

Study Arms (2)

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

Interventions

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).

Forward head postureNon-Forward head posture

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • have headache and dizziness
  • steroid use or muscle relaxants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu Universty

Gaziantep, Şahinbey, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Muscle TonusRespiratory Physiological Phenomena

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
research assistant,physiotherapist

Study Record Dates

First Submitted

January 27, 2020

First Posted

February 5, 2020

Study Start

January 1, 2020

Primary Completion

March 1, 2020

Study Completion

March 10, 2020

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations

TU(1)