Interactive Virtual Telerehabilitation After Total Knee Arthroplasty

Study Overview
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Brief Summary
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The purpose of this clinical trial is to compare the effectiveness of a new interactive virtual telerehabilitation (IVT) system with the conventional program in the rehabilitation of patients after total knee arthroplasty.

Detailed Description
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Patients are distributed into two treatment groups: 1) Group I (control): standard clinical protocol of TKA rehabilitation consisting of 1-hour sessions for 10 days; and 2) Group II (IVT): 1-hour IVT sessions for 10 days (5 sessions under a therapist's supervision to verify the absence of medical complications + 5 sessions performed at home). The IVT is an interactive virtual software-hardware platform that facilitates the development of remote rehabilitation therapy for multiple diseases. Patients receive information required to perform exercise and the therapist remotely monitors the patient's performance. For the purpose of this trial, the IVT system was designed for lower limb motor recovery in patients undergoing TKA.

Official Title
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Effectiveness of an Interactive Virtual Telerehabilitation System in Patients After Total Knee Arthroplasty. A Randomized Controlled Trial

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Other: Interactive Virtual Telerehabilitation (IVT)
* Other: Standard care rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-TKA active range of motion: flexion 80º and extension -10º ABsence of stiffness Ability to walk with the use of a walking aid Ability to read and understand Spanish Ability to understand and accept the trial procedures and to sign an informed consent form in accordance with national legislation Exclusion Criteria: Sensory, cognitive and/or praxic impairment Concomitant medical conditions that may influence the rehabilitation process Discharge destination other than home Patients with any local or systemic complication (e.g., surgical wound infection, suspicion of deep vein thrombosis…) in the three-month follow-up period

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive Virtual Telerehabilitation<br>Rehabilitation by IVT | Other: Interactive Virtual Telerehabilitation (IVT)<br>* Rehabilitation after arthroplasty of knee using IVT<br>* Other names: Rehabilitation procedure (physical manipulation) plus IVT;|
| Active Comparator: Standard rehabilitation care<br>Standard care rehabilitation after total knee arthroplasty | Other: Standard care rehabilitation<br>* Standard care rehabilitation after total knee arthroplasty<br>* Other names: Rehabilitation procedure (physical manipulation);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active knee extension/flexion | Active knee extension/flexion measured by investigator | Change from baseline to 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle strength | Measure of muscle stregth by investigator. That include measures of strength of the quadriceps, Harmstring muscle strength and Timed Getr-UP-ang-Go test | Baseline to 2 weeks | 
| Pain | Measure of pain by visual analog scales | Baseline to 2 weeks | 
| Functional capacity | Measure of functional capacity using questionnaires /Western Ontario and MacMaster University) | Baseline to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee, osteoarthritis, arthroplasty, rehabilitation