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.
Brief Title
Kinesiotape for Edema After Bilateral Total Knee Arthroplasty
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.
Completion Date
Completion Date Type
Actual
Conditions
Arthroplasty Complications
Arthroplasty, Replacement, Knee
Eligibility Criteria
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 85 years;
* inability to tolerate an active rehabilitation program.
* 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 85 years;
* inability to tolerate an active rehabilitation program.
Inclusion Criteria
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.
* 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.
Gender
All
Gender Based
false
Keywords
edema
arthroplasty, knee, bilateral
kinesiotaping
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
50 Years
NCT Id
NCT05013879
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2021-13203
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty
Primary Outcomes
Outcome Description
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.
Outcome Measure
Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities
Outcome Time Frame
During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Secondary Outcomes
Outcome Description
Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)
Outcome Time Frame
During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Outcome Measure
Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale
Outcome Description
Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer
Outcome Time Frame
During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Outcome Measure
Change from baseline and during 1-2-day time intervals for bilateral knee range of motion
Outcome Description
Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living
Outcome Time Frame
At start of study, 4 days after start of study, and day 8
Outcome Measure
Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report
Outcome Description
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.
Outcome Time Frame
During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Outcome Measure
Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Suzanne Babyar
Investigator Email
sbabyar@burke.org
Investigator Phone