Rehabilitation of Reconstructed Shoulder Rotator Cuff

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joy MacDermid, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01499992
First received: December 19, 2011
Last updated: March 18, 2014
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • strength [ Time Frame: 3 month after the surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient satisfaction [ Time Frame: 3 and 6 months after the surgery ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2012
Study Completion Date: January 2013
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
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499992

Locations
Canada, Ontario
St Joseph's health Care London
London, Ontario, Canada, N6A 4V2
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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: March 18, 2014
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 April 17, 2014