Home Vs. Physiotherapy Supervised Rehabilitation After ACL Reconstruction

Study Overview
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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.

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

Conditions
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ACL Reconstruction

Intervention / Treatment
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* Procedure: Home-based rehabilitation program
* Procedure: Physiotherapy-supervised rehabilitation program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based<br>Home-based post-operative rehabilitation program with 4 scheduled physiotherapy sessions over the first 3 post-op months | Procedure: Home-based rehabilitation program<br>* Home-based rehabilitation program that includes 4 physiotherapy sessions in the first 3 post-op months<br>|
| Active Comparator: Physiotherapy supervised<br>Physiotherapy-supervised rehabilitation program including 17 scheduled physiotherapy sessions in the first 3 post-op months | Procedure: Physiotherapy-supervised rehabilitation program<br>* Physiotherapy-supervised rehabilitation program that includes 17 scheduled physiotherapy sessions in the first 3 post-op months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active assisted knee flexion and passive knee extension range of motion |  | pre-op, 6 & 12 weeks post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee flexion and extension range of motion during gait |  | pre-op, 6 & 12 wks post-op | 
| Sagittal plane laxity of the knee |  | pre-op, 6 & 12 wks post-op | 
| Isokinetic quadriceps and hamstrings strength |  | pre-op and 12wks post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior cruciate ligament, Reconstruction, Rehabilitation, Home-based