Shoulder InstabilityNCT05561218
Dispersion of Shoulder Helical Axes Before and After Physical Therapy in Patients With Shoulder Instability
An observational study of Shoulder Instability, run by Istituto Clinico Humanitas.
Trial summary
Shoulder instability is associated with neuromuscular control alterations. Helical Axes (HAs) dispersion is influenced by joint morphology and neuromuscular control and its analysis can be used to quantify the Center of Rotation (CoR) displacement. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Shoulder Instability
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2022to 10 Dec 2023
- 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 18 to 50 years
- All sexes
- Adult
Study population: Patients will be enrolled among Humanitas Hospital outpatients
Who may be able to join
- Age between 18 and 50 years
- Positivity to (at least) one of the three tests described in literature to asses multidirectional shoulder instability: sulcus sign, drawer test and apprehension test
- First episode of glenohumeral dislocation or subluxation treated with assisted reduction
- Presence of anatomical damage compatible with conservative treatment
- Presence of pain or apprehension in the last month
Who cannot join
- Subjects requiring surgical glenohumeral stabilization
- History of shoulder surgery
- Medically unstable subjects who, at the time of inclusion, have a neurological, internal or musculoskeletal disease that could affect functional or motor recovery
About this study
Shoulder instability is associated with neuromuscular control alterations. Helical Axes (HAs) dispersion is influenced by joint morphology and neuromuscular control and its analysis can be used to quantify the Center of Rotation (CoR) displacement.
The aim of the study is to evaluate the effects of an exercise-based training on shoulder HAs dispersion during upper limb movements in patients with shoulder instability and to assess the association between shoulder arthrokinematics and instability-related symptoms.
Read more
25 patients with shoulder instability and 25 healthy subjects (aged between 18 and 50) will be enrolled. The HAs dispersion will be assessed during the performance of two upper limb task, shoulder flexion and shoulder rotation. Kinematics will be recorded by an optoelectronic system and HAs dispersion was computed using Mean Distance (MD) and Mean Angle (MA).
Pain and functional impairments will be assesed through the DASH scale, NRS scale, simple shoulder test (SST). Quality of life will be assessed with SF-12 scale.
Outcomes measures will be evaluated at the enrolment (T0), after one week (T1), after 12 weeks (T2) and after one month (T3). Between T1 and T2 patients perform a 12 weeks home-based exercise protocol and 12 outpatient physical therapy sessions.
Read the detailed description
This will be a single center, observational study that will be conducted in Humanitas Research Hospital.
Patients with symptomatic shoulder instability be enrolled. An orthopaedic surgeon will confirm the diagnosis and recruit patient.
Age-matched heathy subjects, without history of shoulder pain or trauma in the last year, will be enrolled in the study.
Patients will perform a 12 weeks home exercise protocol (5 sessions of 15-20 minutes per week). The exercise-based treatment will be in line with the current literature and will focus on gaining neuromuscular control in different biomechanical contexts.
The home-based training will be divided in 5 different stages. In line with previous studies, the first phase will comprise isometric contractions that aim to the activation of the shoulder muscles and enhance their synergy. The second phase will include closed kinetic chain exercises to enhance physiological neuromuscular activation and shoulder functional stability, as previous studies suggested. The third phase will be a progression of phase 2 since it will use more challenging closed kinetic chain exercises .During phase four, patient will do closed kinetic chain exercises and low-load open kinetic chain exercises. During the fifth phase will include open kinetic chain and task-oriented exercises. Patients will attend one outpatient physical therapy session every week supervised by a physical therapist, who will show the exercises of the following week. Patient will also have a leaflet that will describe in detail each exercise.
Treatment compliance will be tracked every week through a diary in which patients have to report exercises performed.
HAs dispersion, measured during shoulder flexion and shoulder rotation, will be quantified through the parameters of mean distance (MD) and mean angle (MA). MD describes displacement of HAs, providing a measure of CoR movement, whereas MA describes orientation of HAs, showing the ability to perform a movement on a single plane of motion [3-9]. Kinematics will be recorded by optoelectronic system (BTS SMART-DX, Spa), consisting of 8 optical cameras with a sampling frequency of 100 Hz.
Some retro-reflective markers will be positioned on the trunk and upper limb, in particular a cluster of 5 markers on the posterolateral surface of the arm and 6 other markers on the following landmarks: C7, T8, jugular notch, xiphoid process, ulnar styloid and acromial angle.
Pain and functional impairments will be assesed through the DASH scale, NRS scale, simple shoulder test (SST). Quality of life will be assessed with SF-12 scale.
Patient will be evaluated at the enrolment (T0), after one week (T1), at the end of the training of 12 weeks (T2) and after one month from the end of the training (T3). During this last month patient will be asked to stop exercising.
- Conditions
- Shoulder Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
Helical Axes (HAs) dispersion analysis
Changes in HAs dispersion to quantify the displacement of Center of Rotation during upper limb movements was quantified through parameters of MD and MA, which represent HAs displacement and orientation. HAs analysis will be performed through an optoelectronic system (BTS SMART-DX, Spa), consisting of 8 optical cameras and retroreflective markers.
Measured: At baseline, after 1 week, after 12 weeks of training and at 1 month after the training end.
Secondary outcomes (4)
Numeric pain rating scale (0- best outcome, 100 worst outcome)
Changes in shoulder pain
Measured: At baseline, after 12 weeks of training and at 1 month after the training end.
Disability Arm Shoulder Hand (0- best outcome, 100 worst outcome)
Changes in shoulder function
Measured: At baseline, after 12 weeks of training and at 1 month after the training end.
Simple shoulder test (0- worst outcome, 12 best outcome)
Changes in shoulder function
Measured: At baseline, after 12 weeks of training and at 1 month after the training end.
Short form - 12 items (12- best outcome, 57 worst outcome)
Changes in quality of life
Measured: At baseline, after 12 weeks of training and at 1 month after the training end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Oct 2023 (estimated)
- Study completion10 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561218
- Sponsor's protocol ID
- CLF21/02
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dispersion of Shoulder Helical Axes Before and After Physical Therapy in Patients With Shoulder Instability
- ClinicalTrials.gov ID
- NCT05561218
- Acronym / sponsor ID
- CLF21/02
- Conditions
- Shoulder Instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 10 Dec 2023 (estimated)
- First posted
- 30 Sep 2022 (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.
Shoulder instability is associated with neuromuscular control alterations. Helical Axes (HAs) dispersion is influenced by joint morphology and neuromuscular control and its analysis can be used to quantify the Center of Rotation (CoR) displacement.
The aim of the study is to evaluate the effects of an exercise-based training on shoulder HAs dispersion during upper limb movements in patients with shoulder instability and to assess the association between shoulder arthrokinematics and instability-related symptoms.
25 patients with shoulder instability and 25 healthy subjects (aged between 18 and 50) will be enrolled. The HAs dispersion will be assessed during the performance of two upper limb task, shoulder flexion and shoulder rotation. Kinematics will be recorded by an optoelectronic system and HAs dispersion was computed using Mean Distance (MD) and Mean Angle (MA).
Pain and functional impairments will be assesed through the DASH scale, NRS scale, simple shoulder test (SST). Quality of life will be assessed with SF-12 scale.
Outcomes measures will be evaluated at the enrolment (T0), after one week (T1), after 12 weeks (T2) and after one month (T3). Between T1 and T2 patients perform a 12 weeks home-based exercise protocol and 12 outpatient physical therapy sessions.
Detailed description
This will be a single center, observational study that will be conducted in Humanitas Research Hospital.
Patients with symptomatic shoulder instability be enrolled. An orthopaedic surgeon will confirm the diagnosis and recruit patient.
Age-matched heathy subjects, without history of shoulder pain or trauma in the last year, will be enrolled in the study.
Patients will perform a 12 weeks home exercise protocol (5 sessions of 15-20 minutes per week). The exercise-based treatment will be in line with the current literature and will focus on gaining neuromuscular control in different biomechanical contexts.
The home-based training will be divided in 5 different stages. In line with previous studies, the first phase will comprise isometric contractions that aim to the activation of the shoulder muscles and enhance their synergy. The second phase will include closed kinetic chain exercises to enhance physiological neuromuscular activation and shoulder functional stability, as previous studies suggested. The third phase will be a progression of phase 2 since it will use more challenging closed kinetic chain exercises .During phase four, patient will do closed kinetic chain exercises and low-load open kinetic chain exercises. During the fifth phase will include open kinetic chain and task-oriented exercises. Patients will attend one outpatient physical therapy session every week supervised by a physical therapist, who will show the exercises of the following week. Patient will also have a leaflet that will describe in detail each exercise.
Treatment compliance will be tracked every week through a diary in which patients have to report exercises performed.
HAs dispersion, measured during shoulder flexion and shoulder rotation, will be quantified through the parameters of mean distance (MD) and mean angle (MA). MD describes displacement of HAs, providing a measure of CoR movement, whereas MA describes orientation of HAs, showing the ability to perform a movement on a single plane of motion [3-9]. Kinematics will be recorded by optoelectronic system (BTS SMART-DX, Spa), consisting of 8 optical cameras with a sampling frequency of 100 Hz.
Some retro-reflective markers will be positioned on the trunk and upper limb, in particular a cluster of 5 markers on the posterolateral surface of the arm and 6 other markers on the following landmarks: C7, T8, jugular notch, xiphoid process, ulnar styloid and acromial angle.
Pain and functional impairments will be assesed through the DASH scale, NRS scale, simple shoulder test (SST). Quality of life will be assessed with SF-12 scale.
Patient will be evaluated at the enrolment (T0), after one week (T1), at the end of the training of 12 weeks (T2) and after one month from the end of the training (T3). During this last month patient will be asked to stop exercising.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients will be enrolled among Humanitas Hospital outpatients
Key inclusion criteria (5 listed)
- Age between 18 and 50 years
- Positivity to (at least) one of the three tests described in literature to asses multidirectional shoulder instability: sulcus sign, drawer test and apprehension test
- First episode of glenohumeral dislocation or subluxation treated with assisted reduction
- Presence of anatomical damage compatible with conservative treatment
- Presence of pain or apprehension in the last month
Key exclusion criteria (3 listed)
- Subjects requiring surgical glenohumeral stabilization
- History of shoulder surgery
- Medically unstable subjects who, at the time of inclusion, have a neurological, internal or musculoskeletal disease that could affect functional or motor recovery
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
Helical Axes (HAs) dispersion analysis
Time frame: At baseline, after 1 week, after 12 weeks of training and at 1 month after the training end.
Changes in HAs dispersion to quantify the displacement of Center of Rotation during upper limb movements was quantified through parameters of MD and MA, which represent HAs displacement and orientation. HAs analysis will be performed through an optoelectronic system (BTS SMART-DX, Spa), consisting of 8 optical cameras and retroreflective markers.
4 secondary outcomes
Numeric pain rating scale (0- best outcome, 100 worst outcome)
Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.
Disability Arm Shoulder Hand (0- best outcome, 100 worst outcome)
Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.
Simple shoulder test (0- worst outcome, 12 best outcome)
Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.
Short form - 12 items (12- best outcome, 57 worst outcome)
Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Instability, run by Istituto Clinico Humanitas.
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 5 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: status not confirmed, as of the sponsor's last update on 5 Oct 2022. 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?
Results are not available in the source record.
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?
Helical Axes (HAs) dispersion analysis (time frame: At baseline, after 1 week, after 12 weeks of training and at 1 month after the training end.). 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 5 Oct 2022.