NCT01499992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 26, 2011

Completed
6 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 19, 2014

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

December 19, 2011

Last Update Submit

March 18, 2014

Conditions

Full Thickness Rotator Cuff Tear

Keywords

Shoulder rehabilitationRotator cuff tearPhysiotherapyaqua therapyTherapy dosageadjunctive aquatic physical therapy

Outcome Measures

Primary Outcomes (1)

  • strength

    3 month after the surgery

Secondary Outcomes (1)

  • patient satisfaction

    3 and 6 months after the surgery

Study Arms (2)

aquatic physical therapy

EXPERIMENTAL

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 therapyOther: standard care

standard care

NO INTERVENTION

Interventions

Standard physical therapy program PLUS aquatic physical therapyPROCEDURE

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.

aquatic physical therapy
standard careOTHER

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.

aquatic physical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years old

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Joseph's health Care London

London, Ontario, N6A 4V2, Canada

Location

Related Publications (2)

  • 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.

    PMID: 21509132BACKGROUND

  • 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.

    PMID: 12449254RESULT

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Joy MacDernmid, PhD

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Director HULC Clinical Research lab

Study Record Dates

First Submitted

December 19, 2011

First Posted

December 26, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 19, 2014

Record last verified: 2012-01

Locations

CA(1)