Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

NCT ID: NCT00564837

Last Updated: 2010-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2001-02-28

Brief Summary

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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

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Conditions

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ACL Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home-based

Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months

Group Type EXPERIMENTAL

Home-based rehabilitation program

Intervention Type PROCEDURE

Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months

Physiotherapy supervised

Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months

Group Type ACTIVE_COMPARATOR

Physiotherapy-supervised rehabilitation program

Intervention Type PROCEDURE

Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months

Interventions

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Home-based rehabilitation program

Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months

Intervention Type PROCEDURE

Physiotherapy-supervised rehabilitation program

Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Calgary Health Region

OTHER

Sponsor Role collaborator

Olympic Oval Endowment Fund

UNKNOWN

Sponsor Role collaborator

AirCast LLC

INDUSTRY

Sponsor Role collaborator

Fitter International Inc.

INDUSTRY

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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University of Calgary Sport Medicine Centre

Principal Investigators

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Nicholas G. Mohtadi, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Calgary Sport Medicine Centre

Locations

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University of Calgary Sport Medicine Centre

Calgary, Alberta, Canada

Site Status

Countries

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Canada

References

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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. doi: 10.1177/0363546504273051. Epub 2005 Jul 7.

Reference Type RESULT
PMID: 16002493 (View on PubMed)

Other Identifiers

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10339

Identifier Type: -

Identifier Source: org_study_id

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