Rehabilitation of Reconstructed Shoulder Rotator Cuff
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Full Thickness Rotator Cuff Tear |
Procedure: Standard physical therapy program PLUS aquatic physical therapy Other: standard care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Rehabilitation of Reconstructed Shoulder Rotator Cuff : Optimizing Physical Therapy Dosage and Effect of Aquatic Physical Therapy - A Randomized, Factorial Study |
- strength [ Time Frame: 3 month after the surgery ] [ Designated as safety issue: No ]
- patient satisfaction [ Time Frame: 3 and 6 months after the surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: aquatic physical therapy
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.
|
Procedure: Standard physical therapy program PLUS aquatic physical therapy
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.
Other: standard care
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.
|
| No Intervention: standard care |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Kate V Kelly, MPH/Gero | 519-646-6100 ext 64640 | Kate.Kelly@shjc.london.on.ca |
| Canada, Ontario | |
| St Joseph's health Care London | Not yet recruiting |
| London, Ontario, Canada, N6A 4V2 | |
| Contact: Kate Kelly, MPH/Gero 519-646-6100 ext 64640 Kate.Kelly@shjc.london.on.ca | |
| Principal Investigator: | Joy MacDernmid, PhD | St. Joseph's Health Care London |
More Information
Publications:
| Responsible Party: | Joy MacDermid, Co-Director HULC Clinical Research lab, Lawson Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01499992 History of Changes |
| Other Study ID Numbers: | 18466 |
| Study First Received: | December 19, 2011 |
| Last Updated: | January 4, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Lawson Health Research Institute:
|
Shoulder rehabilitation Rotator cuff tear Physiotherapy |
aqua therapy Therapy dosage adjunctive aquatic physical therapy |
ClinicalTrials.gov processed this record on May 23, 2013