Postural; DefectNCT04686123
Efficacy of a Supervised Intervention Protocol on Rounded Shoulder Posture and Shoulder ROM Among Saudi Young Females
A study testing Active Stretching or Self-stretching exercises and Active strengthening Or Self-Strengthening exercises in people with Postural; Defect, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and… Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postural; Defect
- What is being tested?
- Active Stretching or Self-stretching exercises and Active strengthening Or Self-Strengthening exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 29 Sep 2019to 27 Feb 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young Adult Female having a PMLD test score of more than 2.5cm
- Aged between 20-30 years
- No history of shoulder trauma or current shoulder pathology, thoracic scoliosis, or kyphosis deformity.
- Showed self-cooperation for the study
Who cannot join
- Young Adult Female having a PMLD test score of equal to or less than 2.5cm
- History of shoulder trauma or current shoulder pathology, thoracic scoliosis, or kyphosis deformity.
- Showed non-cooperation for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Strengthening and Stretching Exercise on the Resting Length of Pectoralis Minor Muscle and Shoulder Flexion of Young Females With Rounded Shoulder Posture
Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded shoulder posture.
Read the detailed description
Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded shoulder posture.
Randomized sixty female subjects with rounded shoulder posture into two groups: Group A performed active Stretching of PMi along with the strengthening of LTR muscle(n=30); group B performed dynamic Stretching of PMi muscle only. Scores of outcome measures were recorded before and post interventions on day 0, day10th, and day21st, respectively.
- Conditions
- Postural; Defect
- Being tested
- Active Stretching or Self-stretching exercises, Active strengthening Or Self-Strengthening exercises
- Keywords
- Round shoulder posture, Active Stretching, Pectoralis Muscles, Strength Training, Trapezius Muscle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Stretching or Self-stretching exercisesOther
Pectoralis minor muscle was actively stretched under the supervision of a physiotherapist as follows: - 2 sets of 3-stretches/session/day, for 5 consecutive days a week, for 3 weeks
Active strengthening Or Self-Strengthening exercisesOther
Lower trapezius muscle was strengthened under the supervision of a physiotherapist as follows: -2 sets of 5-rep./session/day, for 5 consecutive days in 1st week, progressed to 10 and 20 reps./session/day for 2 weeks and 3 weeks respectively.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A performed active Stretching of Pectoralis Minor (PMi) muscle along with the strengthening of Lower Trapezius muscle under the supervision of a physiotherapist Receives: Other: Active Stretching or Self-stretching exercises; Other: Active strengthening Or Self-Strengthening exercises |
| Group B | Active comparator | Group B performed active Stretching of the Pectoralis Minor (PMi) muscle only under the supervision of a physiotherapist. Receives: Other: Active Stretching or Self-stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting length of Pectoralis Minor (PMi) muscle
It was assessed by Pectoralis Minor Length Distance Test (PMLDT)
Measured: 3-weeks
Shoulder Flexion Range of Motion (SFROM)
It was assessed by a Universal Goniometer
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start29 Sep 2019
- Primary completion26 Dec 2019
- Study completion27 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural; DefectStudies 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
- Model description
- Two-arm parallel groups randomized clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Collaborators
- Majmaah University
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT-Ortho, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686123
- Sponsor's protocol ID
- RRC-2019-21
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Strengthening and Stretching Exercise on the Resting Length of Pectoralis Minor Muscle and Shoulder Flexion of Young Females With Rounded Shoulder Posture
- ClinicalTrials.gov ID
- NCT04686123
- Acronym / sponsor ID
- RRC-2019-21
- Conditions
- Postural; Defect
- Keywords
- Round shoulder posture, Active Stretching, Pectoralis Muscles, Strength Training, Trapezius Muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Collaborators
- Majmaah University
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 26 Dec 2019 (actual)
- Study completion
- 27 Feb 2020 (actual)
- First posted
- 28 Dec 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.
Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded shoulder posture.
Detailed description
Shortening of pectoralis minor (PMi) muscle affects the scapular excursion that results in limited shoulder flexion range of motion (SFROM). The purpose is to evaluate the effect of Stretching of PM muscle along with the strengthening of lower trapezius (LTR) muscle to increase the length of PM muscle (PML) and limited SFROM in young adult females with rounded shoulder posture.
Randomized sixty female subjects with rounded shoulder posture into two groups: Group A performed active Stretching of PMi along with the strengthening of LTR muscle(n=30); group B performed dynamic Stretching of PMi muscle only. Scores of outcome measures were recorded before and post interventions on day 0, day10th, and day21st, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm parallel groups randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Active Stretching or Self-stretching exercises, Other: Active strengthening Or Self-Strengthening exercisesGroup A performed active Stretching of Pectoralis Minor (PMi) muscle along with the strengthening of Lower Trapezius muscle under the supervision of a physiotherapist |
| Group B | Active comparator | Other: Active Stretching or Self-stretching exercisesGroup B performed active Stretching of the Pectoralis Minor (PMi) muscle only under the supervision of a physiotherapist. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Young Adult Female having a PMLD test score of more than 2.5cm
- Aged between 20-30 years
- No history of shoulder trauma or current shoulder pathology, thoracic scoliosis, or kyphosis deformity.
- Showed self-cooperation for the study
Key exclusion criteria (3 listed)
- Young Adult Female having a PMLD test score of equal to or less than 2.5cm
- History of shoulder trauma or current shoulder pathology, thoracic scoliosis, or kyphosis deformity.
- Showed non-cooperation for the study
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 |
|---|---|---|
| Active Stretching or Self-stretching exercisesPectoralis minor muscle was actively stretched under the supervision of a physiotherapist as follows: - 2 sets of 3-stretches/session/day, for 5 consecutive days a week, for 3 weeks | Other | Group A, Group B |
| Active strengthening Or Self-Strengthening exercisesLower trapezius muscle was strengthened under the supervision of a physiotherapist as follows: -2 sets of 5-rep./session/day, for 5 consecutive days in 1st week, progressed to 10 and 20 reps./session/day for 2 weeks and 3 weeks respectively. | Other | Group A |
Primary outcome
Resting length of Pectoralis Minor (PMi) muscle
Time frame: 3-weeks
It was assessed by Pectoralis Minor Length Distance Test (PMLDT)
Shoulder Flexion Range of Motion (SFROM)
Time frame: 3-weeks
It was assessed by a Universal Goniometer
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 28 Dec 2020.
- Individual participant dataSharing planned: No
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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.
AMIR IQBAL, MPT-Ortho principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Stretching or Self-stretching exercises and Active strengthening Or Self-Strengthening exercises in people with Postural; Defect, run by King Saud University at 1 site in Saudi Arabia.
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 3 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 28 Dec 2020. 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 Saudi Arabia. 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?
Resting length of Pectoralis Minor (PMi) muscle (time frame: 3-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?
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 28 Dec 2020.