Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

This study has been completed.

Sponsor:

Collaborators:

Calgary Health Region

Olympic Oval Endowment Fund

AirCast LLC

Fitter International Inc.

Information provided by:

University of Calgary

ClinicalTrials.gov Identifier:

NCT00564837

First received: November 26, 2007

Last updated: January 11, 2010

Last verified: January 2010

History of Changes

Purpose

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.

Condition	Intervention
ACL Reconstruction	Procedure: Home-based rehabilitation program Procedure: Physiotherapy-supervised rehabilitation program


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)

Resource links provided by NLM:

MedlinePlus related topics: Plastic and Cosmetic Surgery Rehabilitation

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:

Active assisted knee flexion and passive knee extension range of motion [ Time Frame: pre-op, 6 & 12 weeks post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knee flexion and extension range of motion during gait [ Time Frame: pre-op, 6 & 12 wks post-op ] [ Designated as safety issue: No ]
Sagittal plane laxity of the knee [ Time Frame: pre-op, 6 & 12 wks post-op ] [ Designated as safety issue: No ]
Isokinetic quadriceps and hamstrings strength [ Time Frame: pre-op and 12wks post-op ] [ Designated as safety issue: No ]


Enrollment:	145
Study Start Date:	September 1999
Study Completion Date:	February 2001
Primary Completion Date:	February 2001 (Final data collection date for primary outcome measure)

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

Eligibility


Ages Eligible for Study:	16 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564837

Locations


Canada, Alberta
University of Calgary Sport Medicine Centre
Calgary, Alberta, Canada, T2N 1N4

Sponsors and Collaborators

University of Calgary

Calgary Health Region

Olympic Oval Endowment Fund

AirCast LLC

Fitter International Inc.

Investigators


Principal Investigator:	Nicholas G. Mohtadi, MD, MSc	University of Calgary Sport Medicine Centre

More Information

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.


Responsible Party:	Nicholas Mohtadi, University of Calgary Sport Medicine Centre
ClinicalTrials.gov Identifier:	NCT00564837 History of Changes
Other Study ID Numbers:	10339
Study First Received:	November 26, 2007
Last Updated:	January 11, 2010
Health Authority:	Canada: Health Canada

Keywords provided by University of Calgary:


Anterior cruciate ligament Reconstruction Rehabilitation Home-based

ClinicalTrials.gov processed this record on September 30, 2016

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