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

Rotator Cuff Tears Clinical Trial

— RCR-SPORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05232773
• Other study ID #: 62/21
• Status: Recruiting
• Start date: January 31, 2022
• Est. completion date: July 30, 2023

Study information

• Verified date: April 2023
• Source: Campus Bio-Medico University
• Contact: Marco Bravi, Dott.
• Phone: 0622541624
• Email: m.bravi[@]policlinicocampus.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: July 30, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Athletes
• Return to Sport
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

Procedure:
• Assessment
Evaluation of clinical and kinematic parameters

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Campus Bio-Medico	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport	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	2 years