Other Instability of Joint, Shoulder RegionNCT04176692
The Effects of Muscle Characteristics on the Control of Shoulder Complex During Functional Movements
An observational study of Other Instability of Joint, Shoulder Region and Strain of Shoulder Muscle (Disorder), run by Tzu Chi University at 1 site in Taiwan.
Trial summary
The movement control of shoulder joint relies not only on the glenohumeral joint, but also the critical contributions from scapulothoracic joint. The relating scapula muscle strength, scapula mobility and, the most important of all, the capacity of neuromuscular control should be integrated into the rehabilitation… Read more about this study
- Who is it for?
- Ages 13 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Other Instability of Joint, Shoulder Region, Strain of Shoulder Muscle (Disorder), Movement Disorders
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2019to 1 Aug 2020
- Phase
- Observational
- 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 13 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: adolescent swimmers in junior or senior high school swimming team with regular training
Who may be able to join
- freestyle swimmers with health shoulders
Who cannot join
- the past or current shoulder pain or disorders are examined by history taking and screening tests: shoulder impingement syndrome, instability, bony deformity, trauma, nerve injury or entrapment.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tzu Chi University
Hualien City, 請選擇, 970
Po-Tsun Chen, 886-3-856-5301 ext. 2493, ptchen120@mail.tcu.edu.tw
About this study
Official title: The Movement Pattern of Shoulder Complex and the Intervention Effects of Therapeutic Exercise in Patients With Proximal Humerus Fracture
The movement control of shoulder joint relies not only on the glenohumeral joint, but also the critical contributions from scapulothoracic joint. The relating scapula muscle strength, scapula mobility and, the most important of all, the capacity of neuromuscular control should be integrated into the rehabilitation program for patients with shoulder disorders. With regarding to the subacromial impingement syndrome or rotator tendinopathy, the status of scapula dyskinesia and dysfunctions were improved significantly after the intervention of scapula-emphasized exercise. But there was no study addressed the relationships between stiffness of relating muscles and the deficits of scapula movement. The stiffness had been shown to serve an important role in functional performance of the corresponding joint. For example, the decreased elasticity of supraspinatus muscle was noticed on affected side comparing in patients with impingement syndrome.Few studies examined the effects of altered muscle stiffness on kinematic performance in shoulder complex. Laudner et al. found that the stiffer the latismuss dorsi muscle was, the less upward rotation and posterior tilting, and the more internal rotation of scapula during arm elevation was exhibited in asymptomatic swimmers. Another study showed that the increased range of external rotation and posterior tilt of scapula during arm elevation were associated with the decreased stiffness of pectoralis minor. The recent study presented that the electromyographic activities and elasticities of middle deltoid, supraspinatus, and infraspinatus muscles correlated significantly with the tissue elasticity during shoulder movement in healthy shoulder. However, there was no scientific information directly to prove the changes in characteristics of rotator cuff function as well as the impacts on kinematic control of shoulder complex. Therefore, the aim of this study is to examine the relationship among characteristics of muscle properties and kinematic control healthy swimmers.
- Conditions
- Other Instability of Joint, Shoulder Region, Strain of Shoulder Muscle (Disorder), Movement Disorders
- Keywords
- scapula dyskinesia, muscle stiffness, scapulohumeral rhythm, electromyography
- Medical subject headings
- Movement Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
scapulohumeral kinematics
the three-dimensional movements of humerus-to-trunk and scapula-to-trunk motions (degree) measured by the electromagnetic motion capture system
Measured: through study completion, an average 11 months
muscle activities
muscle activitiy of upper trapezius, middle deltoid, serratus anterior, infraspinatus, lower trapezius recorded by the surface electromyography
Measured: through study completion, an average 11 months
Secondary outcomes (2)
muscle strength
maximum muscle strength of upper trapezius, middle deltoid, serratus anterior, lower trapezius, internal and external rotators recorded by the hand-held dynamometer
Measured: through study completion, an average 11 months
muscle stiffness
muscle stiffness of upper trapezius, middle deltoid, serratus anterior, infraspinatus, lower trapezius recorded by the tissue-hardness measurement device
Measured: through study completion, an average 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start1 Sep 2019
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Instability of Joint, Shoulder RegionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tzu Chi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Po-Tsun Chen, Tzu Chi University
- Investigators
- Po-Tsun Chen, Principal investigator, Tzu Chi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176692
- Sponsor's protocol ID
- MOST108-2314-B-320 -001-
- Status last verified
- Nov 2019
- First submitted
- 16 Nov 2019
- Last updated
- 25 Nov 2019
- 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 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Movement Pattern of Shoulder Complex and the Intervention Effects of Therapeutic Exercise in Patients With Proximal Humerus Fracture
- ClinicalTrials.gov ID
- NCT04176692
- Acronym / sponsor ID
- MOST108-2314-B-320 -001-
- Conditions
- Other Instability of Joint, Shoulder Region, Strain of Shoulder Muscle (Disorder), Movement Disorders
- Keywords
- scapula dyskinesia, muscle stiffness, scapulohumeral rhythm, electromyography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tzu Chi UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 25 Nov 2019 (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.
The movement control of shoulder joint relies not only on the glenohumeral joint, but also the critical contributions from scapulothoracic joint. The relating scapula muscle strength, scapula mobility and, the most important of all, the capacity of neuromuscular control should be integrated into the rehabilitation program for patients with shoulder disorders. With regarding to the subacromial impingement syndrome or rotator tendinopathy, the status of scapula dyskinesia and dysfunctions were improved significantly after the intervention of scapula-emphasized exercise. But there was no study addressed the relationships between stiffness of relating muscles and the deficits of scapula movement. The stiffness had been shown to serve an important role in functional performance of the corresponding joint. For example, the decreased elasticity of supraspinatus muscle was noticed on affected side comparing in patients with impingement syndrome.Few studies examined the effects of altered muscle stiffness on kinematic performance in shoulder complex. Laudner et al. found that the stiffer the latismuss dorsi muscle was, the less upward rotation and posterior tilting, and the more internal rotation of scapula during arm elevation was exhibited in asymptomatic swimmers. Another study showed that the increased range of external rotation and posterior tilt of scapula during arm elevation were associated with the decreased stiffness of pectoralis minor. The recent study presented that the electromyographic activities and elasticities of middle deltoid, supraspinatus, and infraspinatus muscles correlated significantly with the tissue elasticity during shoulder movement in healthy shoulder. However, there was no scientific information directly to prove the changes in characteristics of rotator cuff function as well as the impacts on kinematic control of shoulder complex. Therefore, the aim of this study is to examine the relationship among characteristics of muscle properties and kinematic control healthy swimmers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- adolescent swimmers in junior or senior high school swimming team with regular training
Key inclusion criteria (1 listed)
- freestyle swimmers with health shoulders
Key exclusion criteria (1 listed)
- the past or current shoulder pain or disorders are examined by history taking and screening tests: shoulder impingement syndrome, instability, bony deformity, trauma, nerve injury or entrapment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
scapulohumeral kinematics
Time frame: through study completion, an average 11 months
the three-dimensional movements of humerus-to-trunk and scapula-to-trunk motions (degree) measured by the electromagnetic motion capture system
muscle activities
Time frame: through study completion, an average 11 months
muscle activitiy of upper trapezius, middle deltoid, serratus anterior, infraspinatus, lower trapezius recorded by the surface electromyography
2 secondary outcomes
muscle strength
Time frame: through study completion, an average 11 months
muscle stiffness
Time frame: through study completion, an average 11 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- 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.
Po-Tsun Chen principal investigator
Tzu Chi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Instability of Joint, Shoulder Region and Strain of Shoulder Muscle (Disorder), run by Tzu Chi University at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Tsun Chen (886-3-856-5301 ext. 2493, ptchen120@mail.tcu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
scapulohumeral kinematics (time frame: through study completion, an average 11 months). 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 25 Nov 2019.