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

NCT05232773 | Unknown

• 1 other identifier: 62/21
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tears; Athletes; Return to Sport

Keywords

Shoulder; Return to Sport; Rehabilitation; Athletes; Rotator Cuff; Rotator Cuff Injuries; Rotator Cuff Tears; Pilot Study; Assessment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group

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

Procedure: Assessment

Healthy subjects

Healthy subjects will undergo evaluations with the same timing as patients in the Experimental group.

Procedure: Assessment

Interventions

Assessment PROCEDURE

Evaluation of clinical and kinematic parameters

Experimental group; Healthy subjects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Competitive and non-competitive athletes undergoing rotator cuff repair surgery at the Unit of Orthopedics and Traumatology of the Campus Bio-Medico University Hospital will be considered eligible.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Fondazione Policlinico Campus Bio-Medico

Roma, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Rocco Papalia, Professor

  Campus Bio-Medico University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Bravi, Dott.

CONTACT

0622541624; m.bravi@policlinicocampus.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 10, 2022
• Study Start: January 31, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

IT (1)