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

NCT ID: NCT05232773

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-31

Study Completion Date

2023-07-30

Brief Summary

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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

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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.

Conditions

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Rotator Cuff Tears Athletes Return to Sport

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Assessment

Intervention Type PROCEDURE

Evaluation of clinical and kinematic parameters

Healthy subjects

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

Assessment

Intervention Type PROCEDURE

Evaluation of clinical and kinematic parameters

Interventions

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Assessment

Evaluation of clinical and kinematic parameters

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Silvia Sterzi

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rocco Papalia, Professor

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

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Fondazione Policlinico Campus Bio-Medico

Roma, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marco Bravi, Dott.

Role: CONTACT

0622541624 ext. +39

Facility Contacts

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Marco MB Bravi, Dott.

Role: primary

0622541624 ext. +39

Other Identifiers

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62/21

Identifier Type: -

Identifier Source: org_study_id

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