Back to resultsEarly Active Rehabilitation After Arthroscopic Rotator Cuff Repair
Primary Purpose
Full Thickness Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
early isometric loading after rotator cuff surgery
passive motion after rotator cuff surgery
Sponsored by
About this trial
This is an interventional treatment trial for Full Thickness Rotator Cuff Tear
Eligibility Criteria
Inclusion Criteria:
- surgery of the rotator cuff after full thickness tear
- informed consent
- understanding german language
Exclusion Criteria:
- previous surgery of the shoulder
- neurological or systemic diseases with impairment of shoulder function
Sites / Locations
- Kepler University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Primary Active
Primary Passive
Arm Description
Early postoperative isometric activation of the rotator cuff
Standard postoperative passive movement rehabilitation protocol
Outcomes
Primary Outcome Measures
Change of Constant Murley Score
Timepoints: Before surgery; 6, 12, 24 weeks after surgery
Secondary Outcome Measures
Change of DASH Score
Timepoints Before surgery; 6, 12, 24 weeks after surgery
Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Range of movement is measured by handheld goniometer
Change of Pain (max; average; rest)
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Pain is measured by Visual Analogue Scale (0-100mm)
Change of Strength (abduction; external Rotation)
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Measurement of Strength is evaluated using a BTE Simulator II Dynamometer (Peak torque in N).
Full Information
NCT ID
NCT02915588
First Posted
September 15, 2016
Last Updated
September 23, 2016
Sponsor
Johannes Kepler University of Linz
1. Study Identification
Unique Protocol Identification Number
NCT02915588
Brief Title
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair
Official Title
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johannes Kepler University of Linz
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Primary Active
Arm Type
Active Comparator
Arm Description
Early postoperative isometric activation of the rotator cuff
Arm Title
Primary Passive
Arm Type
Active Comparator
Arm Description
Standard postoperative passive movement rehabilitation protocol
Intervention Type
Other
Intervention Name(s)
early isometric loading after rotator cuff surgery
Intervention Type
Other
Intervention Name(s)
passive motion after rotator cuff surgery
Primary Outcome Measure Information:
Title
Change of Constant Murley Score
Description
Timepoints: Before surgery; 6, 12, 24 weeks after surgery
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
Change of DASH Score
Description
Timepoints Before surgery; 6, 12, 24 weeks after surgery
Time Frame
up to 24 weeks
Title
Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)
Description
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Range of movement is measured by handheld goniometer
Time Frame
up to 24 weeks
Title
Change of Pain (max; average; rest)
Description
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Pain is measured by Visual Analogue Scale (0-100mm)
Time Frame
up to 24 weeks
Title
Change of Strength (abduction; external Rotation)
Description
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Measurement of Strength is evaluated using a BTE Simulator II Dynamometer (Peak torque in N).
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
surgery of the rotator cuff after full thickness tear
informed consent
understanding german language
Exclusion Criteria:
previous surgery of the shoulder
neurological or systemic diseases with impairment of shoulder function
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Mittermaier, Dr
Organizational Affiliation
Institute of physical medicine and rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler University Hospital
City
Linz
ZIP/Postal Code
4020
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair
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