CClinicalTrials.gg
Status unknownNCT05561218Updated Oct 5, 2022

Dispersion of Shoulder Helical Axes Before and After Physical Therapy in Patients With Shoulder Instability

An observational study in Shoulder Instability, sponsored by Istituto Clinico Humanitas. Status unknown. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-10-05.

Sponsored by Istituto Clinico Humanitas · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
25
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

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.

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.

02

Conditions studied

  • Shoulder Instability

Browse trials for

03

In context

Joint Instability

147 studies on the registry are indexed under Joint Instability; 22 are open to participants now.

This study's planned enrollment of 25 is below the median of 58 across 66 observational studies indexed under Joint Instability.

Browse Joint Instability studies →

Lead sponsor

Istituto Clinico Humanitas is the lead sponsor of 275 studies on the registry; 71 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients will be enrolled among Humanitas Hospital outpatients

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
25 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At baseline, after 1 week, after 12 weeks of training and at 1 month after the training end.

Secondary outcomes

  1. Numeric pain rating scale (0- best outcome, 100 worst outcome)

    Changes in shoulder pain

    Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.

  2. Disability Arm Shoulder Hand (0- best outcome, 100 worst outcome)

    Changes in shoulder function

    Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.

  3. Simple shoulder test (0- worst outcome, 12 best outcome)

    Changes in shoulder function

    Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.

  4. Short form - 12 items (12- best outcome, 57 worst outcome)

    Changes in quality of life

    Time frame: At baseline, after 12 weeks of training and at 1 month after the training end.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05561218
Lead sponsor
Istituto Clinico Humanitas
Responsible party
Sponsor
First posted
Sep 30, 2022
Start date
Oct 10, 2022 (estimated)
Primary completion
Oct 10, 2023 (estimated)
Completion
Dec 10, 2023 (estimated)
Last update
Oct 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion