Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05013879
Collaborator
Burke Rehabilitation Hospital (Other)
40
1
2
25.4
1.6

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if kinesiotaping for edema management will decrease post-operative edema in patients with bilateral total knee arthroplasty. The leg receiving kinesiotaping during inpatient rehabilitation may have decreased edema and pain and improved movement and function when compared to the leg not receiving kinesiotape.

Condition or Disease Intervention/Treatment Phase
  • Device: Kinesio(R)Tape for edema control
N/A

Detailed Description

After being informed about the study and potential risk, all patients undergoing inpatient rehabilitation after bilateral total knee arthroplasty will have Kinesio(R)Tape applied to one randomly selected leg while the other leg serves as a control. Measurement of bilateral leg circumference, knee range of motion, numerical rating scale for pain, and selected questions from the Knee Injury and Osteoarthritis Outcome Score will occur at regular intervals throughout the rehabilitation stay. Patients will receive standard rehabilitation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Repeated measures with two within-subjects factors: time and taped/untaped legRepeated measures with two within-subjects factors: time and taped/untaped leg
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty
Actual Study Start Date :
Oct 18, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Kinesiotape leg plus standard rehabilitation

Kinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty

Device: Kinesio(R)Tape for edema control
Kinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner.
Other Names:
  • kinesiotaping or kinesiological taping
  • No Intervention: Control leg with standard rehabilitation alone

    Control leg receiving standard inpatient rehabilitation alone.

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities [During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8]

      Bilateral circumferences, in centimeters, at the following points: 10 cm above the superior pole of the patella; middle of the knee joint; calf circumference at the broadest part of the calf and at 3 inches below the fibular head landmark; figure of eight method for foot and ankle circumference - a measurement from the lateral malleolus to the navicular tuberosity, under the plantar aspect of the foot towards the tuberosity of the fifth metatarsal, around to the medial malleolus, and posterior to the leg to return to the lateral malleolus.

    Secondary Outcome Measures

    1. Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale [During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8]

      Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)

    2. Change from baseline and during 1-2-day time intervals for bilateral knee range of motion [During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8]

      Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer

    3. Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report [At start of study, 4 days after start of study, and day 8]

      Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living

    4. Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test [During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8]

      Time (sec) to rise from a seated position, walk 10 m, turn, walk back to seat, and sit down. Patient will use appropriate assistive device and have appropriate guarding by a physical therapist.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;

    • 50-85 years of age;

    • able to read and understand English or a hospital-provided translator when consenting for the study;

    • free from contraindications for kinesiotaping (see below); and,

    • able to tolerate an active rehabilitation program.

    Exclusion Criteria:
    • stage III or IV heart failure, stage III or IV renal failure;

    • fragile, very hairy or sensitive skin;

    • anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites

    • active skin rashes or infections or skin lesions in the lower extremity;

    • prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives;

    • prior history of lower extremity lymphedema;3

    • prior history of lower extremity venous or arterial disease;

    • post-operative complications in the surgical sites;4

    • partial joint arthroplasty or revision arthroplasty of one or both knees;1,5

    • inability to give informed consent offered in English or through a hospital-provided translator

    • age less than 50 years or over 75 years;

    • inability to tolerate an active rehabilitation program.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Burke Rehabilitation Hospital White Plains New York United States 10605

    Sponsors and Collaborators

    • Montefiore Medical Center
    • Burke Rehabilitation Hospital

    Investigators

    • Principal Investigator: Suzanne Babyar, PT, PhD, Burke Rehabilitation Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Montefiore Medical Center
    ClinicalTrials.gov Identifier:
    NCT05013879
    Other Study ID Numbers:
    • 2021-13203
    First Posted:
    Aug 19, 2021
    Last Update Posted:
    Oct 26, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Montefiore Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 26, 2021