Posture Disorders in ChildrenNCT02190331
Effects of a Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Posture Adolescents
A study testing Interventional program postural correction training in people with Posture Disorders in Children, run by Faculdade de Motricidade Humana at 1 site in Portugal.
Trial summary
To evaluate the effects of a 32-weeks resistance and stretching training program applied in Physical Education classes on forward head and protracted shoulder Portuguese adolescents (15-17 years old). Read more about this study
- Who is it for?
- Ages 15 to 17 years
- Conditions the study is for
- Posture Disorders in Children
- What is being tested?
- Interventional program postural correction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 275 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2012to Oct 2013
- 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 15 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- adolescents with 15-17 years old with cervical angle lower than 50º and the shoulder angle lower than 52º
Who cannot join
- Participants were excluded if their CV and SH angle was equal or higher than 50º and 52º respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic kyphosis.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Technical University of Lisbon
Lisbon, Cruz Quebrada-Dafundo, 1499-002
About this study
Official title: The Effects of Training and Detraining After an 8 Month Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Postures in Adolescents
- To evaluate the effects of a 32-weeks resistance and stretching training program applied in Physical Education classes on forward head and protracted shoulder Portuguese adolescents (15-17 years old).
- To evaluate on adolescents submitted to strength and stretching exercises the effects of a 16-week detraining period after the end of the intervention protocol.
Read the detailed description
A prospective, randomized and controlled study will be conducted over a 12 month period, with adolescents of two public secondary schools, in Lisbon.
At the beginning, a total of 275 adolescent students aged 15-17 years old will be evaluated with photogrammetry. The students will be screened by measuring the cervical (CV) and shoulder (SH) angle with photogrammetry. If the CV and SH angle were less than 50º and 52º respectively, the adolescent was considered to have forward head posture (FHP) and protracted shoulder (PS) and was selected to the study.
Participants will be excluded if their CV and SH angle was equal or higher than 50º and 52º respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic kyphosis.
After these the eligible students will be randomly assigned to the control or interventional group. The intervention group will begin a 32-week stretching and strengthening program to be performed in the last part of the Physical Education (PE) classes. The control group will only participate in the PE classes. Since the 32th week until the 48th week the experimental group will not follow the interventional training program and both groups will only participate in PE classes.
The program will be constituted by four strengthening exercises and three stretching exercises and is designed based on the assumption that the use of therapeutic exercise is effective in the correction of specific neck and shoulder postures. The training exercise protocol will be designed for the correction of the FHP and PS, targeting to the selective activation of lower trapezius, middle trapezius and rhomboids, to the lengthening of the pectoralis major, pectoralis minor and sternocleidomastoid and to the improvement of the deep cervical flexor function This program is going to be applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.
The postural assessment of the groups will be performed in the beginning and after 36 and 48-weeks intervention period.
- Conditions
- Posture Disorders in Children
- Being tested
- Interventional program postural correction training, Control Group physical education classes
- Keywords
- Detraining, Neck, Exercise, Posture, Rehabilitation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional program postural correction trainingOther
The postural correction training program was applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.
Control Group physical education classesOther
Only performed the physical education classes
| Study group | Role | What they receive |
|---|---|---|
| Interventional program | Experimental | The training protocol is constituted by 4 strengthening exercises (Side Lying External Rotation, Prone Horizontal Abduction with External Rotation, Y to I exercise and Chin Tuck) and 3 stretching exercises(one- Sided Unilateral Self Stretch Exercise, one-sided Unilateral Self Stretch Exercise, Static Sternocleidomastoid Stretch and Static Levator Scapulae Stretch Receives: Other: Interventional program postural correction training |
| Control group | Active comparator | The control group will only participate in the Physical Education classes Receives: Other: Control Group physical education classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in postural angles (cervical and shoulder angle)
We will assess the Cervical angle - the angle formed at the intersection of a horizontal line through the spinous process of C7 and a line to the tragus of the ear and the shoulder angle - The angle formed at the intersection of the line between the midpoint of the humerus and the spinous process of C7 and the horizontal line through the midpoint of the humerus.
Measured: 36 and 48 weeks
Secondary outcomes (1)
the American Shoulder and Elbow Surgeons Standardized questionnaire
Measured: 36 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posture Disorders in ChildrenStudies 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
- Investigator
- Enrolment
- 275 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculdade de Motricidade Humana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Ruivo, Faculdade de Motricidade Humana
- Investigators
- Rodrigo Ruivo, Master, Principal investigator, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190331
- Sponsor's protocol ID
- SFRH/BD/77633/2011
- Status last verified
- Jul 2014
- First submitted
- 11 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruivo RM, Pezarat-Correia P, Carita AI. Effects of a Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Posture in Adolescents. J Manipulative Physiol Ther. 2017 Jan;40(1):1-10. doi: 10.1016/j.jmpt.2016.10.005. Epub 2016 Nov 11.
PubMed 27842938Ruivo 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 26028408
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Training and Detraining After an 8 Month Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Postures in Adolescents
- ClinicalTrials.gov ID
- NCT02190331
- Acronym / sponsor ID
- SFRH/BD/77633/2011
- Conditions
- Posture Disorders in Children
- Keywords
- Detraining, Neck, Exercise, Posture, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (actual)
- Lead sponsor
- Faculdade de Motricidade HumanaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 15 Jul 2014 (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.
- To evaluate the effects of a 32-weeks resistance and stretching training program applied in Physical Education classes on forward head and protracted shoulder Portuguese adolescents (15-17 years old).
- To evaluate on adolescents submitted to strength and stretching exercises the effects of a 16-week detraining period after the end of the intervention protocol.
Detailed description
A prospective, randomized and controlled study will be conducted over a 12 month period, with adolescents of two public secondary schools, in Lisbon.
At the beginning, a total of 275 adolescent students aged 15-17 years old will be evaluated with photogrammetry. The students will be screened by measuring the cervical (CV) and shoulder (SH) angle with photogrammetry. If the CV and SH angle were less than 50º and 52º respectively, the adolescent was considered to have forward head posture (FHP) and protracted shoulder (PS) and was selected to the study.
Participants will be excluded if their CV and SH angle was equal or higher than 50º and 52º respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic kyphosis.
After these the eligible students will be randomly assigned to the control or interventional group. The intervention group will begin a 32-week stretching and strengthening program to be performed in the last part of the Physical Education (PE) classes. The control group will only participate in the PE classes. Since the 32th week until the 48th week the experimental group will not follow the interventional training program and both groups will only participate in PE classes.
The program will be constituted by four strengthening exercises and three stretching exercises and is designed based on the assumption that the use of therapeutic exercise is effective in the correction of specific neck and shoulder postures. The training exercise protocol will be designed for the correction of the FHP and PS, targeting to the selective activation of lower trapezius, middle trapezius and rhomboids, to the lengthening of the pectoralis major, pectoralis minor and sternocleidomastoid and to the improvement of the deep cervical flexor function This program is going to be applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.
The postural assessment of the groups will be performed in the beginning and after 36 and 48-weeks intervention period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional program | Experimental | Other: Interventional program postural correction trainingThe training protocol is constituted by 4 strengthening exercises (Side Lying External Rotation, Prone Horizontal Abduction with External Rotation, Y to I exercise and Chin Tuck) and 3 stretching exercises(one- Sided Unilateral Self Stretch Exercise, one-sided Unilateral Self Stretch Exercise, Static Sternocleidomastoid Stretch and Static Levator Scapulae Stretch |
| Control group | Active comparator | Other: Control Group physical education classesThe control group will only participate in the Physical Education classes |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- adolescents with 15-17 years old with cervical angle lower than 50º and the shoulder angle lower than 52º
Key exclusion criteria (1 listed)
- Participants were excluded if their CV and SH angle was equal or higher than 50º and 52º respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic kyphosis.
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 |
|---|---|---|
| Interventional program postural correction trainingThe postural correction training program was applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher. | Other | Interventional program |
| Control Group physical education classesOnly performed the physical education classes | Other | Control group |
Primary outcome
change in postural angles (cervical and shoulder angle)
Time frame: 36 and 48 weeks
We will assess the Cervical angle - the angle formed at the intersection of a horizontal line through the spinous process of C7 and a line to the tragus of the ear and the shoulder angle - The angle formed at the intersection of the line between the midpoint of the humerus and the spinous process of C7 and the horizontal line through the midpoint of the humerus.
1 secondary outcome
the American Shoulder and Elbow Surgeons Standardized questionnaire
Time frame: 36 and 48 weeks
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 15 Jul 2014.
- Derived from this study: PubMed 27842938Ruivo RM, Pezarat-Correia P, Carita AI. Effects of a Resistance and Stretching Training Program on Forward Head and Protracted Shoulder Posture in Adolescents. J Manipulative Physiol Ther. 2017 Jan;40(1):1-10. doi: 10.1016/j.jmpt.2016.10.005. Epub 2016 Nov 11.
- Derived from this study: 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.
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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.
Rodrigo Ruivo, Master principal investigator
University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional program postural correction training in people with Posture Disorders in Children, run by Faculdade de Motricidade Humana at 1 site in Portugal.
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 1 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 15 Jul 2014. 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 Portugal. 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?
change in postural angles (cervical and shoulder angle) (time frame: 36 and 48 weeks). 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 NCT02190331, which also lists 2 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 15 Jul 2014.