Rotator Cuff Surgery in Athletes: From Rehabilitation to Return to Sport

Recruiting

• Conditions: Athletes; Return to Sport; Rotator Cuff Tears
• Interventions: Procedure: Assessment

• Registration Number: NCT05232773
• Lead Sponsor: Campus Bio-Medico University

Brief Summary

The main goal of this project is to study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport made by a set of objective shoulder evaluation indicators that are easy to use in clinical context. Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo four evaluation at different times. Healthy subjects will undergo evaluations with the same timing as patients.

Detailed Description

Clinical, kinematic and shoulder muscle strength assessments to collect data useful to define objective criteria for progression between rehabilitation phases will be performed according to the following times:

* T1 - 4-6 weeks after surgery: PROM assessment, pain assessment at rest and during PROM, Constant-Murley score (CMS).

* T2 - 6-12 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during PROM and AROM tasks, scapular humeral rhythm, CMS.

* T3 - 12-16 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), pain assessment at rest and during PROM and AROM tasks, scapular humeral rhythm, isometric strength assessment, CMS; joint proprioception assessment (joint position sense).

* T4 - 16-24 weeks after surgery: AROM assessment (flexion in scapular plane, abduction, external and internal rotation), scapular humeral rhythm, isometric strength assessment, CMS, joint proprioception assessment (joint position sense), movement speed and smoothness.

Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo the evaluations. Healthy subjects will undergo evaluations with the same timing as patients.

Study Timeline

• Study Start: 2022-01-31
• Study First Submitted: 2022-01-31
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age between 18 and 65 years
• Mini Mental Status Examination (MMSE)> 24
• Acceptance and signature of informed consent

Exclusion Criteria

• Presence of other pathologies that can compromise the standard post-operative course (shoulder instability; reoperation for failed rotator cuff repair; neurological and cognitive problems)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy subjects	Assessment	Healthy subjects will undergo evaluations with the same timing as patients in the Experimental group.
Experimental group	Assessment	Enrolled patients will undergo supervised rehabilitation treatment for rotator cuff repair according to a standardized protocol (5 days/week) and will undergo clinical, kinematic and shoulder muscle strength assessments to collect data useful to define objective criteria for progression between rehabilitation phases. Assessment will be performed at four different times. The clinical evaluation of the shoulder is carried out through the Constant-Murley Score (CMS). Pain will be assessed through the visual analogical scale (VAS). Kinematic assessment (shoulder ROM, scapula-humeral rhythm, movement smoothness, movement speed) will be assessed through magneto-inertial measurements units (M-IMU). The maximal voluntary isometric contraction (MVIC) of shoulder flexor, abductor and rotator cuff muscles of the affected limb will be measured by the Chronojump Boscosystem® Force Sensor Kit

Primary Outcome Measures

Name	Time	Method
To study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport	2 years	To create tool to support the multidisciplinary team involved in the decision-making process of progress between the various stages of rehabilitation and in the transition from the rehabilitation phase to the re-athletization phase after surgical repair of the rotator cuff of the shoulder in athletes

Trial Locations

Locations (1)

Fondazione Policlinico Campus Bio-Medico; 🇮🇹 Roma, Italy