Rehabilitation of Reconstructed Shoulder Rotator Cuff
Primary Purpose
Full Thickness Rotator Cuff Tear
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard physical therapy program PLUS aquatic physical therapy
standard care
Sponsored by
About this trial
This is an interventional supportive care trial for Full Thickness Rotator Cuff Tear focused on measuring Shoulder rehabilitation, Rotator cuff tear, Physiotherapy, aqua therapy, Therapy dosage, adjunctive aquatic physical therapy
Eligibility Criteria
Inclusion Criteria:
- full thickness rotator cuff tear treated by arthroscopic or mini-open repair by a specialized upper extremity surgeons
- mentally competent
- able to read and write
- able to return for follow-up
- 18-65 years old
Exclusion Criteria:
- associated surgical procedures (Concomitant fractures, capsular releases surgical decompression)
- nerve injury
- neurological conditions
- irreparable massive rotator cuff tear, and
- comorbid health problems that limit rehabilitation potential (Rheumatoid arthritis, Diabetes).
Sites / Locations
- St Joseph's health Care London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
aquatic physical therapy
standard care
Arm Description
aquatic physical therapy program which will be conducted twice weekly for 10 weeks and will include a 40-50 minute hydrotherapy session emphasizing range of motion and light resistive exercises of the arm, primarily focussing on the shoulder.
Outcomes
Primary Outcome Measures
strength
Secondary Outcome Measures
patient satisfaction
Full Information
NCT ID
NCT01499992
First Posted
December 19, 2011
Last Updated
March 18, 2014
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01499992
Brief Title
Rehabilitation of Reconstructed Shoulder Rotator Cuff
Official Title
Rehabilitation of Reconstructed Shoulder Rotator Cuff : Optimizing Physical Therapy Dosage and Effect of Aquatic Physical Therapy - A Randomized, Factorial Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study to define the optimal rehabilitation for clients with full thickness rotator cuff reconstruction, with two goals: 1. Finding the optimal physical therapy dosage in enhancing post-operative outcomes of shoulder pain, shoulder joint range of motion, shoulder muscle strength, upper extremity function; and 2. Finding the effect of aquatic physical therapy in enhancing the post-operative outcomes.
Detailed Description
Measurement devices:
Biodex: Biodex system is a muscle strength testing and rehabilitation instrument used in the testing and rehabilitation services for shoulder, elbow, wrist, hip, knee and ankle. Modes of operation for exercise and testing include isokinetic, passive, isometric, isotonic, and reactive eccentric. Patients are tested for their muscle performance for the required number of repetitions in the required mode. The muscle performance is measured by calculating the average peak torque (in Nm) and analyzed across the group of patients.
Goniometer: A manual devise used to measure joint range of motion. Visual Analogue Scale: A scale with 0 to 10, with 0 being no pain, and 10 being severe pain.
Measurement procedure:
All the subjects posted for surgery will be tested prior to and again 6 weeks following surgery for:
Shoulder Pain is measured using a visual analog scale. Shoulder Range of motion is measured using a standard goniometer. Shoulder Muscle performances are measured using Biodex.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear
Keywords
Shoulder rehabilitation, Rotator cuff tear, Physiotherapy, aqua therapy, Therapy dosage, adjunctive aquatic physical therapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aquatic physical therapy
Arm Type
Experimental
Arm Description
aquatic physical therapy program which will be conducted twice weekly for 10 weeks and will include a 40-50 minute hydrotherapy session emphasizing range of motion and light resistive exercises of the arm, primarily focussing on the shoulder.
Arm Title
standard care
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Standard physical therapy program PLUS aquatic physical therapy
Intervention Description
2. Standard physical therapy program PLUS aquatic physical therapy: The above PLUS a aquatic physical therapy program which will be conducted twice weekly for 10 weeks and will include a 40-50 minute hydrotherapy session emphasizing range of motion and light resistive exercises of the arm, primarily focusing on the shoulder. The program will start with general mobility of the other upper limb joints to allow time for preconditioning of the painful shoulder. Shoulder exercises will emphasize flexion, rotation and abduction and a slow transition from pain-free range to the restricted range of motion to maximize the effectiveness of the heat and buoyancy.
Intervention Type
Other
Intervention Name(s)
standard care
Intervention Description
Total of 12 weeks; each exercise session will be 20 -30 minutes of direct contact and additional supervised exercise as defined by assignment and stage.
Primary Outcome Measure Information:
Title
strength
Time Frame
3 month after the surgery
Secondary Outcome Measure Information:
Title
patient satisfaction
Time Frame
3 and 6 months after the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
full thickness rotator cuff tear treated by arthroscopic or mini-open repair by a specialized upper extremity surgeons
mentally competent
able to read and write
able to return for follow-up
18-65 years old
Exclusion Criteria:
associated surgical procedures (Concomitant fractures, capsular releases surgical decompression)
nerve injury
neurological conditions
irreparable massive rotator cuff tear, and
comorbid health problems that limit rehabilitation potential (Rheumatoid arthritis, Diabetes).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy MacDernmid, PhD
Organizational Affiliation
St. Joseph's Health Care London
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph's health Care London
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21509132
Citation
Ellenbecker TS, Sueyoshi T, Winters M, Zeman D. Descriptive report of shoulder range of motion and rotational strength six and 12 weeks following arthroscopic superior labral repair. N Am J Sports Phys Ther. 2008 May;3(2):95-106.
Results Reference
background
PubMed Identifier
12449254
Citation
Roddey TS, Olson SL, Gartsman GM, Hanten WP, Cook KF. A randomized controlled trial comparing 2 instructional approaches to home exercise instruction following arthroscopic full-thickness rotator cuff repair surgery. J Orthop Sports Phys Ther. 2002 Nov;32(11):548-59. doi: 10.2519/jospt.2002.32.11.548.
Results Reference
result
Learn more about this trial
Rehabilitation of Reconstructed Shoulder Rotator Cuff
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