Gait Rehabilitation Following an Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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A randomized control trial where subjects following an anterior cruciate ligament reconstruction will be randomized to either a control group who will receive the normal rehabilitation or an experimental group who will perform a 2-week gait rehabilitation using the anti-gravity treadmill in addition to the normal rehabilitation. The intervention will be added to the existing care received at Linkoping University Hospital 2 weeks post-surgery, while the evaluation will be performed in week 5 and 12 post-surgery using: a 3D-gait analysis (with the Qualisys software), self-reported function questionnaires and a clinical examination.

Official Title
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Early Initiated Gait Rehabilitation Using the Anti-gravity Treadmill Following an Anterior Cruciate Ligament Reconstruction

Conditions
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Complete Tear, Knee, Anterior Cruciate Ligament

Intervention / Treatment
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* Other: Gait rehabilitating with reduced bodyweight
* Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Anterior cruciate ligament injury occurred a minimum of 3 weeks prior to surgery Exclusion Criteria: Previous Anterior cruciate ligament injury Other knee injury with restrictions that could interfere with rehabilitation Other injury or disease that could interfere with rehabilitation Inability to understand the information

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gait rehabilitation<br>Will perform 2 weeks of gait rehabilitation using the anti gravity treadmill. Intervention will start 2 weeks post-surgery. This rehabilitation will be performed simultaneously as the patient receives the standardized rehabilitation at Linkoping University Hospital. | Other: Gait rehabilitating with reduced bodyweight<br>* Patients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery.<br>Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital<br>* Exercises for increased movement and circulation performed on a daily basis.<br>|
| Active Comparator: Control group<br>Will only receive the standardized rehabilitation at Linkoping University Hospital. | Other: Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital<br>* Exercises for increased movement and circulation performed on a daily basis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 dimensional gait analysis | A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg | 5 weeks post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Injury and Osteoarthritis Outcome Score | The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self-administered questionnaire which consists of 42 items which can be sub grouped into five categories. These categories are pain, other disease-specific symptoms, activities of daily living (ADL), sport and recreation function and lastly knee-related quality of life. | 5 weeks post-surgery | 
| International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC) | The IKDC subjective knee evaluation form is a self-administered questionnaire which contains 18 items divided into 3 subgroups. These subgroups are symptoms, sports and daily activities and the patients current and previous levels of knee function. | 12 weeks post-surgery | 
| 3 dimensional gait analysis | A 10 Oqus camera system by Qualisys, Sweden integrated with 3 Kistler forcplates is used. The primary outcome is peak knee flexion during stance phase for injured leg | 12 weeks post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL-reconstruction, Gait rehabilitation, Anti Gravity treadmill, ACL-rehabilitation