Rehabilitation of Reconstructed Shoulder Rotator Cuff

NCT ID: NCT01499992

Last Updated: 2014-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Full Thickness Rotator Cuff Tear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard physical therapy program PLUS aquatic physical therapy

Intervention Type: PROCEDURE

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.

standard care

Intervention Type: OTHER

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.

standard care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Joy MacDermid

Co-Director HULC Clinical Research lab

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joy MacDernmid, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Health Care London

Locations

St Joseph's health Care London

London, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 21509132 (View on PubMed)

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.

Reference Type: RESULT

PMID: 12449254 (View on PubMed)

Other Identifiers

18466

Identifier Type: -

Identifier Source: org_study_id