Clinical trial NCT01499992: 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
Overall status: COMPLETED
Phase: NA
Conditions: Full Thickness Rotator Cuff Tear
Keywords: Shoulder rehabilitation
Rotator cuff tear
Physiotherapy
aqua therapy
Therapy dosage
adjunctive aquatic physical therapy
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: strength
timeFrame: 3 month after the surgery
Secondary outcomes:
measure: patient satisfaction
timeFrame: 3 and 6 months after the surgery
Other outcomes:
Locations:
city: London
country: Canada
facility: St Joseph's health Care London
state: Ontario
Study officials:
affiliation: St. Joseph's Health Care London
name: Joy MacDernmid, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.