Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05232773 |
Other study ID # |
62/21 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.