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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03681106
Other study ID # Kinesiotaping
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 14, 2018
Est. completion date February 18, 2020

Study information

Verified date March 2021
Source Istituto Ortopedico Galeazzi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 71
Est. completion date February 18, 2020
Est. primary completion date February 18, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kinesio Tex
Kinesio Tex tape on the operated limb

Locations

Country Name City State
Italy IRCCS Istituto Ortopedico Galeazzi Milan

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bade MJ, Stevens-Lapsley JE. Restoration of physical function in patients following total knee arthroplasty: an update on rehabilitation practices. Curr Opin Rheumatol. 2012 Mar;24(2):208-14. doi: 10.1097/BOR.0b013e32834ff26d. Review. — View Citation

Donec V, Krišciunas A. The effectiveness of Kinesio Taping® after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13. — View Citation

Morris D, Jones D, Ryan H, Ryan CG. The clinical effects of Kinesio® Tex taping: A systematic review. Physiother Theory Pract. 2013 May;29(4):259-70. doi: 10.3109/09593985.2012.731675. Epub 2012 Oct 22. Review. — View Citation

Williams S, Whatman C, Hume PA, Sheerin K. Kinesio taping in treatment and prevention of sports injuries: a meta-analysis of the evidence for its effectiveness. Sports Med. 2012 Feb 1;42(2):153-64. doi: 10.2165/11594960-000000000-00000. Review. — View Citation

Wozniak-Czekierda W, Wozniak K, Hadamus A, Bialoszewski D. Use of Kinesiology Taping in Rehabilitation after Knee Arthroplasty: a Randomised Clinical Study. Ortop Traumatol Rehabil. 2017 Oct 31;19(5):461-468. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Timed Up and Go test Functional test pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary 10 meters walking test Functional test pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary Barthel Index Autonomy outcome pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary Functional Independence Measure Autonomy outcome pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary 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
Secondary Thigh circumference Thigh circumference expressed in cm pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary Leg circumference Leg circumference expressed in cm pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary Ankle circumference Ankle circumference expressed in cm pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
Secondary 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
Secondary R0 measured using bioimpedance body impedance pre-operative, 3rd post-operative day, 7th post operative day, 13th post-operative day
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