Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair

September 23, 2016 updated by: Johannes Kepler University of Linz

Early Active Rehabilitation After Arthroscopic Rotator Cuff Repair: A Prospective Randomized Pilot Study

The purpose of the study is to compare two different rehabilitation protocols after arthroscopic rotator cuff surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria, 4020
        • Kepler University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Primary Active
Early postoperative isometric activation of the rotator cuff
Other: early isometric loading after rotator cuff surgery
Active Comparator: Primary Passive
Standard postoperative passive movement rehabilitation protocol
Other: passive motion after rotator cuff surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Constant Murley Score
Time Frame: up to 24 weeks
Timepoints: Before surgery; 6, 12, 24 weeks after surgery
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of DASH Score
Time Frame: up to 24 weeks
Timepoints Before surgery; 6, 12, 24 weeks after surgery
up to 24 weeks
Change of Active range of Motion (Flexion, Extension, Abduction, Internal Rotation, External Rotation)
Time Frame: up to 24 weeks
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Range of movement is measured by handheld goniometer
up to 24 weeks
Change of Pain (max; average; rest)
Time Frame: up to 24 weeks
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Pain is measured by Visual Analogue Scale (0-100mm)
up to 24 weeks
Change of Strength (abduction; external Rotation)
Time Frame: up to 24 weeks
Timepoints: Before surgery; 6, 12, 24 weeks after surgery; Measurement of Strength is evaluated using a BTE Simulator II Dynamometer (Peak torque in N).
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Kepler University of Linz

Investigators

  • Principal Investigator: Christian Mittermaier, Dr, Institute of Physical Medicine and Rehabilitation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Estimate)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMR-Shoulder-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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