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NCT Number: NCT01499992

Rehabilitation of Reconstructed Shoulder Rotator Cuff

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.

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Key information

Conditions

Full Thickness Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Joseph's health Care London

London, Ontario, N6A 4V2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Standard physical therapy program PLUS aquatic physical therapy

Procedure
  • 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

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.

Primary outcomes

  1. strength

    Time frame: 3 month after the surgery

Secondary outcomes

  1. patient satisfaction

    Time frame: 3 and 6 months after the surgery

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Rehabilitation of Reconstructed Shoulder Rotator Cuff : Optimizing Physical Therapy Dosage and Effect of Aquatic Physical Therapy - A Randomized, Factorial Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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