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

NCT05561218 | Unknown

• 1 other identifier: CLF21/02
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Shoulder Instability

Outcome Measures

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.

  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)

  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)

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

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

  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)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients will be enrolled among Humanitas Hospital outpatients

You may qualify if:

• 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

You may not qualify if:

• Subjects requiring surgical glenohumeral stabilization
• History of shoulder surgery

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: September 30, 2022
• Study Start: October 10, 2022
• Primary Completion: October 10, 2023
• Study Completion: December 10, 2023
• Last Updated: October 5, 2022

Record last verified: 2022-10