Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

ACL Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00564837
• Other study ID #: 10339
• Status: Completed
• Phase: N/A
• First received: November 26, 2007
• Last updated: January 11, 2010
• Start date: September 1999
• Est. completion date: February 2001

Study information

• Verified date: January 2010
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: February 2001
• Est. primary completion date: February 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ACL Reconstruction

Intervention

Procedure:
• Home-based rehabilitation program
Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months
• Physiotherapy-supervised rehabilitation program
Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months

Locations

Country	Name	City	State
Canada	University of Calgary Sport Medicine Centre	Calgary	Alberta

Sponsors (5)

Lead Sponsor	Collaborator
University of Calgary	AirCast LLC, Calgary Health Region, Fitter International Inc., Olympic Oval Endowment Fund

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Active assisted knee flexion and passive knee extension range of motion		pre-op, 6 & 12 weeks post-op	No
Secondary	Knee flexion and extension range of motion during gait		pre-op, 6 & 12 wks post-op	No
Secondary	Sagittal plane laxity of the knee		pre-op, 6 & 12 wks post-op	No
Secondary	Isokinetic quadriceps and hamstrings strength		pre-op and 12wks post-op	No