Kinesio® Tex Taping for Post Total Knee Replacement Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to better understand the effect of Kinesio Taping applied using the Neurotaping technique on patients who underwent total knee arthroplasty surgery. Patients will be randomized in two groups: in the first group patients will follow a protocol of usual rehabilitation, while the second group will do the same but add the Kinesio Taping application. Main outcome will be the effect on edema, secondary outcome the effect on functionality after 13 days post surgery.

Official Title
-----------------
Efficacy of Kinesio® Tex Taping on Edema and Early Functional Outcome of Post Total Knee Replacement Patients: a Randomized-controlled Trial

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Device: Kinesio Tex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Program of total knee replacement; Signing and accepting informed consent. Exclusion Criteria: pre-operative Barthel Index score < 70; program of revision of total knee replacement; grade III-IV heart failure; grade III-IV kidney failure; hypersensitive skin or intolerance to taping; Active cutaneous infection or open skin lesion on the sites of taping positioning; Body Mass Index > 34,9; Pregnant women; Not accepting informed consent; Impossibility to follow usual rehabilitation treatment.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kinesiotape<br>Kinesio Tex taping treatment for 10 days + usual care | Device: Kinesio Tex<br>* Kinesio Tex tape on the operated limb<br>|
| No Intervention: Control<br>usual care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee circumference | Difference between pre-operative knee circumference and 13th post-operative day knee circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test | Functional test | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| 10 meters walking test | Functional test | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Barthel Index | Autonomy outcome | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Functional Independence Measure | Autonomy outcome | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Knee range of motion | Flexion/extension passive/active range of motion of operated knee | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Thigh circumference | Thigh circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Leg circumference | Leg circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Ankle circumference | Ankle circumference expressed in cm | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| Pain Visual Analogue Scale | The Pain Visual Analogue Scale scale consists of a straight line, 10 cm long, printed on a white sheet, the endpoints, 0 and 10, defining respectively no pain at all and pain as bad as it could be. The patient must mark the line to indicate his perception of his level of pain at that time. | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 
| R0 measured using bioimpedance | body impedance | pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee Osteoarthritis, Total Knee Arthroplasty, Kinesiotaping, Neuro taping, Rehabilitation