Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.

Detailed Description
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After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.

Official Title
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Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial

Conditions
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Knee Injuries

Intervention / Treatment
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* Device: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18-40 (either sex) Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft Exclusion Criteria: Patients with significant cognitive deficit (MEC<24). Patients with epilepsy or severe vision problems Pregnant patients Previous surgery on the reconstructed knee, excluding arthroscopy Previous anterior cruciate ligament reconstruction on either knee Sustained concurrent injury to the contralateral knee Concomitant collateral ligament and/or meniscal repair Presence of symptomatic tibiofemoral osteoarthritis

Ages Eligible for Study
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Minimum Age: 18 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: Virtual reality<br>Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol | Device: Virtual reality<br>* Embodiment of a healthy virtual body in virtual reality and action observation/motor imagery of the subject's virtual body performing high-level lower limb exercises.<br>|
| No Intervention: Standard intervention<br>Standard rehabilitation protocol only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | Baseline (day 1 post-surgery) | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 4 weeks | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 12 weeks | 
| The International Knee Documentation Committee (IKDC) Subjective Knee Form | Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms). | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | Baseline | 
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | 4 weeks | 
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | 12 weeks | 
| Isometric quadriceps strength | Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons) | 9 months | 
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | Baseline | 
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | 4 weeks | 
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | 12 weeks | 
| Knee extension active range of motion | Measured with a digital goniometer (smartphone app) | 9 months | 
| Time taken to return to sporting activity | Taken retrospectively at 9 months, number of days from surgery to full return to sport | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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virtual reality, embodiment, rehabilitation, anterior cruciate ligament reconstruction