Musculoskeletal AbnormalitiesNCT03006497
Exercise Program Based on Motor Learning and Forward Head Posture Correction
A study testing Exercise program based on motor learning principles in people with Musculoskeletal Abnormalities and Deformity, run by Eleni Kapreli.
Trial summary
The aim of this study is to investigate the efficiency of an exercise program based on principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic patients. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Abnormalities, Deformity
- What is being tested?
- Exercise program based on motor learning principles
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 30 Dec 2017
- 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 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Students at Technological Educational Institute of Sterea Ellada,
- Aged 18-26 years old
- Males and females
- Craniocervical angle < 50 degrees (statical Forward Head Posture in standing position)
Who cannot join
- Injury or surgery in cervical spine
- Accompanying neurologic, musculoskeletal or mental problems
- Any medical administration
- Intense continuous or intermittent neck pain
- BMI >25
- Participation in any rehabilitation or physiotherapy sessions considering neck dysfunction the last 6 months
- Change in physical activities during the research period of 6 weeks
About this study
Official title: The Efficacy of Exercise Program Based on Motor Learning Principles in Correction of Forward Head Posture
The aim of this study is to investigate the efficiency of an exercise program based on principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic patients.
Read the detailed description
Epidemiological studies have shown that bad posture and poor body control occurs at puberty, with forward head posture (FHP) and rounded shoulders being the most common biomechanical deviations in sagittal plane. The FHP is defined as an anterior displacement of the head with hyperextension of the cervical spine and this is associated with a reduction in the length of the upper portion of the trapezius, posterior portion of the cervical extensor muscles, the sternocleidomastoid and the levator scapulae. FHP can be evaluated by measuring craniovertebral angle (CVA) which is defined as the angle between a horizontal line passing through C7 and a line extending from the tragus of the ear to C7.
CVA, smaller than 50 degrees, constitute a criterion of abnormal posture of cervical spine, suggesting FHP. People with FHP present incomplete balance control, thereby affecting the position of the center of gravity and motor control of the body. The establishment of altered motor control strategies could lead to balance disorders, neck muscle imbalances, chronic neck pain and even respiratory dysfunction.
Despite the efforts of researchers to create effective treatment programs based on strength training and stretching exercises, positive long-term results have been a problem in FHP correction. For this reason, re-education of posture and body alignment, through exercise programs based on motor learning, with cognitive elements (attention, motivation, feedback, reasoning), could be proved a more effective therapeutic strategy.
- Conditions
- Musculoskeletal Abnormalities, Deformity
- Being tested
- Exercise program based on motor learning principles
- Keywords
- neck, motor control, motor learning
- Medical subject headings
- Musculoskeletal Abnormalities, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise program based on motor learning principlesOther
The exercise program will include simple activities exposing volunteers in various environmental conditions with a view to adjust their head posture in such conditions. The progressiveness of exercises will be based on the two-dimensional classification system of Gentile (1987). Furthermore, external attentional focus will be used.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | The control group will not participate in any exercise program. However, at the end, home based exercises and special advice will be given to the participants. |
| Intervention | Experimental | The intervention group will participate in an exercise program based on motor learning principles for 4 weeks/3 sessions per week, for a total of 12 sessions of 30-45 minutes each. Receives: Other: Exercise program based on motor learning principles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Static Forward Head Posture (sFHP)
The sFHP will be assessed by calculating the craniovertebral angle through lateral photographs in standing. The craniovertebral angle is the angle between the line extending from the tragus of the ear to the 7th cervical vertebra (C7) spinous process and the horizontal line through C7. The calculation of the angle on the photographs will be carried out using AutoCAD software. A performance curve will be developed using the measurements during the 4 weeks practice and 2 weeks after the end of protocol (retension test).
Measured: Change from Baseline sFHP at 4 weeks and Change from Baseline sFHP at 6 weeks
Change of Dynamic Forward Head Posture (dFHP)
The dFHP will be assessed by calculating the craniovertebral angle through video motion during walking. The craniovertebral angle is the angle between the line extending from the tragus of the ear to the 7th cervical vertebra (C7) spinous process and the horizontal line through C7. The calculation of the angle The calculation of the angle will be carried out using Kinovea and AutoCAD softwares. dFHP will be regarded as a transfer test. Transfer tests are tests involving some novel situation, so that people must adapt the skill they have been practicing to the characteristics of this new situation.
Measured: Change from Baseline dFHP t at 4 weeks and Change from Baseline dFHP at 6 weeks
Secondary outcomes (12)
Overall self-esteem
Sorensen self-esteem test will be used which has been translated into Greek and has been tested for its reliability and validity.
Measured: Baseline; week 4; week 6
Mood
A ten point Visual Analogue Scale (VAS) will be used
Measured: Baseline; week 4; week 6
Overall physical fatigue
A ten point VAS scale will be used
Measured: Baseline; week 4; week 6
Overall mental fatigue
A ten point VAS scale will be used
Measured: Baseline; week 4; week 6
Attention-concentration
Attention- concentration questionnaire will be used. It has been developed in Greek language and has been tested for its reliability and validity.
Measured: Baseline; week 4; week 6
Verbal Comprehension index
The Wechsler Adult Intelligence Scale (WAIS-IV) (similarities) will be used. Participants will be given a number of pairs of words or concepts and have to describe how they are similar.
Measured: Baseline
Perceptual Organization Index
The WAIS-IV (Matrix Reasoning) will be used. Participants will be given pictures of sets of drawings and have to choose the correct drawing that is missing from each set.
Measured: Baseline
Change in Deep neck flexors endurance
The first stage of the test allows for the quantification of the performance of craniocervical flexion action, while the second stage examines the isometric endurance of deep neck flexors, during which the participant adopts the crook lying position. The air chamber of a pressure biofeedback device is positioned under the cervical area and the participant is asked to perform a head nod action at five different pressure levels (22, 24, 26, 28 and 30 mmHg). The test is initially performed at a pressure level of 22 mmHg and proceeds to the next pressure level if the participant is able to maintain in the position for 10 seconds on three separate occasions. The Chattanooga stabilizer pressure biofeedback will be used.
Measured: Change from Baseline Deep neck flexors endurance at 4 weeks and Change from Baseline Deep neck flexors endurance at 6 weeks
Change in Discomfort
The Discomfort will be assessed using a ten point grade VAS scale, where 0 is no pain and 10 worst pain.
Measured: Change from Baseline discomfort at 4 weeks and Change from Baseline discomfort at 6 weeks
Change in Area of Discomfort
The Discomfort (Head, Neck, Shoulders and upper arms, Middle back, Lower back, Forearms and Wrists/hands areas) will be assessed using a body chart
Measured: Change from Baseline discomfort at 4 weeks and Change from Baseline discomfort at 6 weeks
Weight
Measurement of weight with scale (kilograms)
Measured: Baseline
Height
Measurement of height (cm)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal AbnormalitiesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eleni Kapreli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eleni Kapreli, Technological Education Institute of Sterea Ellada
- Investigators
- Eleni V Kapreli, MSc, PhD, Study chair, Technological Educational Institute of Sterea ElladaStefani Argyrou, BSc, Principal investigator, Technological Educational Institute of Sterea Ellada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006497
- Sponsor's protocol ID
- PHYSMSC1
- Status last verified
- Jan 2019
- First submitted
- 3 Dec 2016
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Individual Participant Data (IPD) are to be shared with other researchers, when it will be available
Publications
Christakou A, Zervas Y, Psychountaki M, Stavrou NA. Development and validation of the attention questionnaire of rehabilitated athletes returning to competition. Psychol Health Med. 2012;17(4):499-510. doi: 10.1080/13548506.2011.630402. Epub 2011 Nov 25.
PubMed 22114988Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Respiratory weakness in patients with chronic neck pain. Man Ther. 2013 Jun;18(3):248-53. doi: 10.1016/j.math.2012.10.014. Epub 2012 Nov 28.
PubMed 23199797Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Reliability of the chin tuck neck flexion test for assessing endurance of short neck flexors in healthy individuals. Physiother Theory Pract. 2015 May;31(4):299-302. doi: 10.3109/09593985.2014.1002874. Epub 2015 Jan 14.
PubMed 25585517Han J, Park S, Kim Y, Choi Y, Lyu H. Effects of forward head posture on forced vital capacity and respiratory muscles activity. J Phys Ther Sci. 2016 Jan;28(1):128-31. doi: 10.1589/jpts.28.128. Epub 2016 Jan 30.
PubMed 26957743Kang JH, Park RY, Lee SJ, Kim JY, Yoon SR, Jung KI. The effect of the forward head posture on postural balance in long time computer based worker. Ann Rehabil Med. 2012 Feb;36(1):98-104. doi: 10.5535/arm.2012.36.1.98. Epub 2012 Feb 29.
PubMed 22506241Kapreli E, Vourazanis E, Strimpakos N. Neck pain causes respiratory dysfunction. Med Hypotheses. 2008;70(5):1009-13. doi: 10.1016/j.mehy.2007.07.050. Epub 2007 Oct 23.
PubMed 17959320Rosario JL, Diogenes MS, Mattei R, Leite JR. Can sadness alter posture? J Bodyw Mov Ther. 2013 Jul;17(3):328-31. doi: 10.1016/j.jbmt.2012.12.001. Epub 2012 Dec 23.
PubMed 23768277Ruivo RM, Carita AI, Pezarat-Correia P. The effects of training and detraining after an 8 month resistance and stretching training program on forward head and protracted shoulder postures in adolescents: Randomised controlled study. Man Ther. 2016 Feb;21:76-82. doi: 10.1016/j.math.2015.05.001. Epub 2015 May 13.
PubMed 26028408Silva AG, Johnson MI. Does forward head posture affect postural control in human healthy volunteers? Gait Posture. 2013 Jun;38(2):352-3. doi: 10.1016/j.gaitpost.2012.11.014. Epub 2012 Dec 7.
PubMed 23219786Wulf G, Mercer J, McNevin N, Guadagnoli MA. Reciprocal influences of attentional focus on postural and suprapostural task performance. J Mot Behav. 2004 Jun;36(2):189-99. doi: 10.3200/JMBR.36.2.189-199.
PubMed 15130869
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Exercise Program Based on Motor Learning Principles in Correction of Forward Head Posture
- ClinicalTrials.gov ID
- NCT03006497
- Acronym / sponsor ID
- PHYSMSC1
- Conditions
- Musculoskeletal Abnormalities, Deformity
- Keywords
- neck, motor control, motor learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eleni KapreliUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- May 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
The aim of this study is to investigate the efficiency of an exercise program based on principles of motor learning in correction of Forward Head Position (FHP) in asymptomatic patients.
Detailed description
Epidemiological studies have shown that bad posture and poor body control occurs at puberty, with forward head posture (FHP) and rounded shoulders being the most common biomechanical deviations in sagittal plane. The FHP is defined as an anterior displacement of the head with hyperextension of the cervical spine and this is associated with a reduction in the length of the upper portion of the trapezius, posterior portion of the cervical extensor muscles, the sternocleidomastoid and the levator scapulae. FHP can be evaluated by measuring craniovertebral angle (CVA) which is defined as the angle between a horizontal line passing through C7 and a line extending from the tragus of the ear to C7.
CVA, smaller than 50 degrees, constitute a criterion of abnormal posture of cervical spine, suggesting FHP. People with FHP present incomplete balance control, thereby affecting the position of the center of gravity and motor control of the body. The establishment of altered motor control strategies could lead to balance disorders, neck muscle imbalances, chronic neck pain and even respiratory dysfunction.
Despite the efforts of researchers to create effective treatment programs based on strength training and stretching exercises, positive long-term results have been a problem in FHP correction. For this reason, re-education of posture and body alignment, through exercise programs based on motor learning, with cognitive elements (attention, motivation, feedback, reasoning), could be proved a more effective therapeutic strategy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –The control group will not participate in any exercise program. However, at the end, home based exercises and special advice will be given to the participants. |
| Intervention | Experimental | Other: Exercise program based on motor learning principlesThe intervention group will participate in an exercise program based on motor learning principles for 4 weeks/3 sessions per week, for a total of 12 sessions of 30-45 minutes each. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Students at Technological Educational Institute of Sterea Ellada,
- Aged 18-26 years old
- Males and females
- Craniocervical angle < 50 degrees (statical Forward Head Posture in standing position)
Key exclusion criteria (7 listed)
- Injury or surgery in cervical spine
- Accompanying neurologic, musculoskeletal or mental problems
- Any medical administration
- Intense continuous or intermittent neck pain
- BMI >25
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 |
|---|---|---|
| Exercise program based on motor learning principlesThe exercise program will include simple activities exposing volunteers in various environmental conditions with a view to adjust their head posture in such conditions. The progressiveness of exercises will be based on the two-dimensional classification system of Gentile (1987). Furthermore, external attentional focus will be used. | Other | Intervention |
Primary outcome
Change in Static Forward Head Posture (sFHP)
Time frame: Change from Baseline sFHP at 4 weeks and Change from Baseline sFHP at 6 weeks
The sFHP will be assessed by calculating the craniovertebral angle through lateral photographs in standing. The craniovertebral angle is the angle between the line extending from the tragus of the ear to the 7th cervical vertebra (C7) spinous process and the horizontal line through C7. The calculation of the angle on the photographs will be carried out using AutoCAD software. A performance curve will be developed using the measurements during the 4 weeks practice and 2 weeks after the end of protocol (retension test).
Change of Dynamic Forward Head Posture (dFHP)
Time frame: Change from Baseline dFHP t at 4 weeks and Change from Baseline dFHP at 6 weeks
The dFHP will be assessed by calculating the craniovertebral angle through video motion during walking. The craniovertebral angle is the angle between the line extending from the tragus of the ear to the 7th cervical vertebra (C7) spinous process and the horizontal line through C7. The calculation of the angle The calculation of the angle will be carried out using Kinovea and AutoCAD softwares. dFHP will be regarded as a transfer test. Transfer tests are tests involving some novel situation, so that people must adapt the skill they have been practicing to the characteristics of this new situation.
12 secondary outcomes
Overall self-esteem
Time frame: Baseline; week 4; week 6
Mood
Time frame: Baseline; week 4; week 6
Overall physical fatigue
Time frame: Baseline; week 4; week 6
Overall mental fatigue
Time frame: Baseline; week 4; week 6
Attention-concentration
Time frame: Baseline; week 4; week 6
Verbal Comprehension index
Time frame: Baseline
Perceptual Organization Index
Time frame: Baseline
Change in Deep neck flexors endurance
Time frame: Change from Baseline Deep neck flexors endurance at 4 weeks and Change from Baseline Deep neck flexors endurance at 6 weeks
Change in Discomfort
Time frame: Change from Baseline discomfort at 4 weeks and Change from Baseline discomfort at 6 weeks
Change in Area of Discomfort
Time frame: Change from Baseline discomfort at 4 weeks and Change from Baseline discomfort at 6 weeks
Weight
Time frame: Baseline
Height
Time frame: Baseline
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 9 Jan 2019.
- Background: PubMed 22114988Christakou A, Zervas Y, Psychountaki M, Stavrou NA. Development and validation of the attention questionnaire of rehabilitated athletes returning to competition. Psychol Health Med. 2012;17(4):499-510. doi: 10.1080/13548506.2011.630402. Epub 2011 Nov 25.
- Background: PubMed 23199797Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Respiratory weakness in patients with chronic neck pain. Man Ther. 2013 Jun;18(3):248-53. doi: 10.1016/j.math.2012.10.014. Epub 2012 Nov 28.
- Background: PubMed 25585517Dimitriadis Z, Kapreli E, Strimpakos N, Oldham J. Reliability of the chin tuck neck flexion test for assessing endurance of short neck flexors in healthy individuals. Physiother Theory Pract. 2015 May;31(4):299-302. doi: 10.3109/09593985.2014.1002874. Epub 2015 Jan 14.
- Background: PubMed 26957743Han J, Park S, Kim Y, Choi Y, Lyu H. Effects of forward head posture on forced vital capacity and respiratory muscles activity. J Phys Ther Sci. 2016 Jan;28(1):128-31. doi: 10.1589/jpts.28.128. Epub 2016 Jan 30.
- Background: PubMed 22506241Kang JH, Park RY, Lee SJ, Kim JY, Yoon SR, Jung KI. The effect of the forward head posture on postural balance in long time computer based worker. Ann Rehabil Med. 2012 Feb;36(1):98-104. doi: 10.5535/arm.2012.36.1.98. Epub 2012 Feb 29.
- Background: PubMed 17959320Kapreli E, Vourazanis E, Strimpakos N. Neck pain causes respiratory dysfunction. Med Hypotheses. 2008;70(5):1009-13. doi: 10.1016/j.mehy.2007.07.050. Epub 2007 Oct 23.
- Background: PubMed 23768277Rosario JL, Diogenes MS, Mattei R, Leite JR. Can sadness alter posture? J Bodyw Mov Ther. 2013 Jul;17(3):328-31. doi: 10.1016/j.jbmt.2012.12.001. Epub 2012 Dec 23.
- Background: PubMed 26028408Ruivo RM, Carita AI, Pezarat-Correia P. The effects of training and detraining after an 8 month resistance and stretching training program on forward head and protracted shoulder postures in adolescents: Randomised controlled study. Man Ther. 2016 Feb;21:76-82. doi: 10.1016/j.math.2015.05.001. Epub 2015 May 13.
- Background: PubMed 23219786Silva AG, Johnson MI. Does forward head posture affect postural control in human healthy volunteers? Gait Posture. 2013 Jun;38(2):352-3. doi: 10.1016/j.gaitpost.2012.11.014. Epub 2012 Dec 7.
- Background: PubMed 15130869Wulf G, Mercer J, McNevin N, Guadagnoli MA. Reciprocal influences of attentional focus on postural and suprapostural task performance. J Mot Behav. 2004 Jun;36(2):189-99. doi: 10.3200/JMBR.36.2.189-199.
- Individual participant dataSharing planned: Undecided. Individual Participant Data (IPD) are to be shared with other researchers, when it will be available
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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.
Eleni V Kapreli, MSc, PhD study chair
Technological Educational Institute of Sterea Ellada
Stefani Argyrou, BSc principal investigator
Technological Educational Institute of Sterea Ellada
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program based on motor learning principles in people with Musculoskeletal Abnormalities and Deformity, run by Eleni Kapreli.
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 4 inclusion and 7 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 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Static Forward Head Posture (sFHP) (time frame: Change from Baseline sFHP at 4 weeks and Change from Baseline sFHP at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03006497, which also lists 10 linked publications.
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 9 Jan 2019; AzTrials last refreshed its copy on 28 Oct 2026.