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Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction
This study has been completed.
Sponsor:
University of Calgary
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
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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 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:
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 ]
Secondary Outcome Measures:
- 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 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00564837
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:
| 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 |
Keywords provided by University of Calgary:
|
Anterior cruciate ligament Reconstruction Rehabilitation Home-based |
ClinicalTrials.gov processed this record on August 16, 2017