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临床试验/NCT05232773
NCT05232773招募中不适用

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

Campus Bio-Medico University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
42
试验地点
1
主要终点
To study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

To study and define a rehabilitative flow-chart for athletes' rehabilitation and return to sport

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Sterzi

Full Professor

Campus Bio-Medico University

研究点 (1)

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