Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction - Tabular View

Tracking Information

First Received Date ^ICMJE

November 26, 2007

Last Updated Date

November 26, 2007

Start Date ^ICMJE

September 1999

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Active assisted knee flexion and passive knee extension range of motion [ Time Frame: pre-op, 6 & 12 weeks post-op ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Knee flexion and extension range of motion during gait [ Time Frame: pre-op, 6 & 12 wks post-op ]
Sagittal plane laxity of the knee [ Time Frame: pre-op, 6 & 12 wks post-op ]
Isokinetic quadriceps and hamstrings strength [ Time Frame: pre-op and 12wks post-op ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

Official Title ^ICMJE

Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)

Brief Summary

This study was designed to determine whether or not there were any differences in knee range of motion, both statically and during gait, sagittal plane knee laxity, and quadriceps and hamstrings strength in patients three months post-ACL reconstruction with a bone-patellar tendon-bone autograft based on their performance of a primarily home based rehabilitation program or a standard physiotherapy-supervised program.

Detailed Description

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

ACL Reconstruction

Intervention ^ICMJE

Procedure: Home-based rehabilitation program
Procedure: Physiotherapy-supervised rehabilitation program

Study Arms / Comparison Groups

Experimental: Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months
Active Comparator: Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months

Publications *

Grant JA, Mohtadi NG, Maitland ME, Zernicke RF. Comparison of home versus physical therapy-supervised rehabilitation programs after anterior cruciate ligament reconstruction: a randomized clinical trial. Am J Sports Med. 2005 Sep;33(9):1288-97. Epub 2005 Jul 7.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

145

Completion Date

February 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

16 years of age or older
Surgery at least 6 weeks after injury to allow for a return of full range of motion, minimize swelling, and offset strength deficits due to pain/swelling14,28
ACL reconstruction with a bone-patellar tendon-bone autograft

Exclusion Criteria:

Previous or concomitant reconstruction of any knee ligament to either knee
Ongoing knee abnormality unrelated to the ACL injury (eg, evidence of changes on radiographs consistent with osteoarthritis)
Professional athletes or workers' compensation patients
Complications during surgery (eg, inadequate graft fixation requiring protocol modification)
Patients without access to local physical therapy services

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00564837

Responsible Party

Study ID Numbers ^ICMJE

10339

Study Sponsor ^ICMJE

University of Calgary

Collaborators ^ICMJE

Calgary Health Region
Olympic Oval Endowment Fund
AirCast LLC
Fitter International Inc.

Investigators ^ICMJE

Principal Investigator:

Nicholas G. Mohtadi, MD, MSc

University of Calgary Sport Medicine Centre

Information Provided By

University of Calgary

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP