Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
ACL Reconstruction	Procedure: Home-based rehabilitation program; Procedure: Physiotherapy-supervised rehabilitation program	Not Applicable

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	145 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Comparison of Home Vs. Physiotherapy-Supervised Rehabilitation Programs Following Reconstruction of the Anterior Cruciate Ligament (ACL)
Study Start Date :	September 1999
Actual Primary Completion Date :	February 2001
Actual Study Completion Date :	February 2001

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

Inclusion Criteria:

1. 16 years of age or older
2. 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
3. ACL reconstruction with a bone-patellar tendon-bone autograft

Exclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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
First Posted:	November 28, 2007
Last Update Posted:	January 12, 2010
Last Verified:	January 2010

Keywords provided by University of Calgary:

Anterior cruciate ligament; Reconstruction; Rehabilitation; Home-based