The Clinical Observation on Taping After Total Knee Replacement

Study Overview
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Brief Summary
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The investigators will conduct a single-blind, randomized controlled trial of 100 patients with total knee replacement. Patients will be randomly assigned into a control group and an intervention group.Both groups received same rehabilitation procedures after surgery,except intervention group also received taping applications throughout all rehabilitation period.Then, the patients will be reevaluated to determine changes in lower extremity function, edema, pain,knee range of motion, and muscle strength of quadriceps femoris and hamstring.

Official Title
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The Effectiveness of the Nine Castle Net Format Taping After Total Knee Replacement in Early Postoperative Rehabilitation Period. A Randomized Controlled Trial

Conditions
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Total Knee Replacement

Intervention / Treatment
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* Other: the Nine Castle Net Format Taping
* Other: traditional rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: soft-tissue swelling and pain after total knee replacement agree to participate the study and signing of informed consent Exclusion Criteria: severe cognitive and language barriers that can not be used to evaluate patients with pain and swelling failure of important organs, such as heart, lung, liver and kidney deep venous thrombosis thrombophlebitis varicose veins (stage II-IVaccording to Marshall) and venous insufficiency (stadium 2-3 according to Widmer) participants with infection in the areas close to the knee joint, or allergy to tape enrollment in another clinical trial involving physical therapy or an investigational drug
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The intervention group<br>The intervention group will be received the Nine Castle Net Format taping and the traditional rehabilitation throughout all hospitalization period.We will exchange the new taping for Every two days. | Other: the Nine Castle Net Format Taping<br>* The intervention group received traditional rehabilitation and Taping throughout all rehabilitation period.The taping including a Nine Castle Net Format of taping in both side of surgery knee.We will exchange the new taping for every two days， for a week.Traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.<br>|
| Other: The control group<br>The control group will be received the traditional rehabilitation during the hospitalization period.The traditional rehabilitation included occupational therapy and physical therapy. | Other: traditional rehabilitation<br>* traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Knee Edema at 1 week | Leg Circumference Measurements | Baseline and at 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Activities of Daily Living (ADL) at 1 week | The Barthel index | Baseline and at 1 week | 
| Change from Baseline Knee Pain at 1 week | Numeric Pain Rating Scale（NPRS）,Numeric Pain Rating Scale on a 1(no pain)to 10(worst pain imaginable)scale, 0 No pain,1 2 3 Mild pain, 4 5 6 Moderate pain,7 8 9 10 Worst possible pain | Baseline and at 1 week | 
| Change from Baseline Knee range of motion at 1 week | The Range of Motion Measurements | Baseline and at 1 week | 
| Change from Baseline muscle strength of quadriceps femoris and hamstring at 1 week | Manual Muscle Test（MMT） | Baseline and at 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Taping, Rehabilitation, Edema, Pain