CClinicalTrials.gg
Status unknownNCT05232773RCR-SPORTUpdated Apr 6, 2023

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

An observational study in Rotator Cuff Tears, Athletes and Return to Sport, sponsored by Campus Bio-Medico University. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-06.

Sponsored by Campus Bio-Medico University · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
42
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rotator Cuff Tears
  • Athletes
  • Return to Sport

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Keywords

  • Shoulder
  • Return to Sport
  • Rehabilitation
  • Athletes
  • Rotator Cuff
  • Rotator Cuff Injuries
  • Rotator Cuff Tears
  • Pilot Study
  • Assessment
03

In context

Rotator Cuff Injuries

734 studies on the registry are indexed under Rotator Cuff Injuries; 161 are open to participants now.

This study's planned enrollment of 42 is below the median of 67 across 162 observational studies indexed under Rotator Cuff Injuries.

Browse Rotator Cuff Injuries studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
42 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureAssessment

    Evaluation of clinical and kinematic parameters

06

What researchers measure

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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Fondazione Policlinico Campus Bio-Medico
    Roma, 00128, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05232773
Lead sponsor
Campus Bio-Medico University
Responsible party
Silvia Sterzi (Full Professor, Campus Bio-Medico University) — Principal investigator
First posted
Feb 10, 2022
Start date
Jan 31, 2022
Primary completion
Jul 30, 2023 (estimated)
Completion
Jul 30, 2023 (estimated)
Last update
Apr 6, 2023

Study contacts

Marco Bravi, Dott.
Contact
m.bravi@policlinicocampus.it
0622541624 ext. +39
Rocco Papalia, Professor
principal investigator · Campus Bio-Medico University

Oversight

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 Apr 2023. You cannot join it, but the record below documents what was studied.

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