- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04644991
The Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
February 2, 2022 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
The Investigation of the Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
With the initiation of prosthesis use following lower extremity amputations, the body shows biomechanical changes according to the amputation level, and as a result, it develops adaptation mechanisms on both the healthy and ampute sides.
It has been reported that the most common secondary pathology caused by these mechanisms developed to compensate the amputated side is lower back pain and adaptation mechanisms vary according to the presence of pain.
Adaptation strategies in transfemoral amputees cause permanent changes in the connective tissue structure properties of the toracolumbar region and reduce the contribution of these structures to dynamic stability.
It has been reported that with the fascia correction technique, one of the kinesiological taping techniques, the connective tissue fiber alignment can be rearranged and the degree of stiffness can be reduced.
Before the intervention, biomechanical properties of the toracolumbar region structures with MyotonPro and postural stability measurements with TekScan will be taken.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Istanbul Saglık Bilimleri University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Being between the ages of 18-60
- Having unilateral transfemoral amputation
- Using prosthesis for at least 6 months
- Good prosthesis comfort
Exclusion Criteria:
- Body mass index>30
- Having a history of surgery in the lumbar region in past 6 months
- Participating in a physiotherapy and rehabilitation program for a low back pain past six months
- Neurological and / or orthopedic disorders other than amputation
- Having low back pain for at least 3 months before amputation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesiotape
Experimental group consisting of transfemoral amputees who kinesiology tape will be applied
|
Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.
Participants will be asked to walk as fast as they can for 6 minutes.
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Sham Comparator: ShamKinesiotape
The placebo group of transfemoral amputees who shame kinesiology tape will be applied
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Participants will be asked to walk as fast as they can for 6 minutes.
Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of Postural Stability
Time Frame: Changes from baseline of center of gravity displacement at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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The center of gravity displacement (cm2) will be measured at standing position on force platform during 30sn
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Changes from baseline of center of gravity displacement at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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Measurement of Stiffness
Time Frame: Changes from baseline of stifness of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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Stiffness of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
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Changes from baseline of stifness of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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Measurement of Creep
Time Frame: Changes from baseline of creep of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying
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Creep value of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
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Changes from baseline of creep of thoracolumbal fascia at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Low back pain
Time Frame: Changes from baseline of low back pain at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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Low back pain will be measured by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain)
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Changes from baseline of low back pain at following 6 minutes walking test, at immediately after kinesiology tape applying and at 30. minutes following kinesiology tape applying.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gailey R, Allen K, Castles J, Kucharik J, Roeder M. Review of secondary physical conditions associated with lower-limb amputation and long-term prosthesis use. J Rehabil Res Dev. 2008;45(1):15-29. doi: 10.1682/jrrd.2006.11.0147.
- Morgenroth DC, Orendurff MS, Shakir A, Segal A, Shofer J, Czerniecki JM. The relationship between lumbar spine kinematics during gait and low-back pain in transfemoral amputees. Am J Phys Med Rehabil. 2010 Aug;89(8):635-43. doi: 10.1097/PHM.0b013e3181e71d90.
- Murray AM, Gaffney BM, Davidson BS, Christiansen CL. Biomechanical compensations of the trunk and lower extremities during stepping tasks after unilateral transtibial amputation. Clin Biomech (Bristol, Avon). 2017 Nov;49:64-71. doi: 10.1016/j.clinbiomech.2017.08.010. Epub 2017 Aug 30.
- Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.
- Yahia L, Rhalmi S, Newman N, Isler M. Sensory innervation of human thoracolumbar fascia. An immunohistochemical study. Acta Orthop Scand. 1992 Apr;63(2):195-7. doi: 10.3109/17453679209154822.
- Stecco C, Day JA. The fascial manipulation technique and its biomechanical model: a guide to the human fascial system. Int J Ther Massage Bodywork. 2010 Mar 17;3(1):38-40. doi: 10.3822/ijtmb.v3i1.78. No abstract available.
- Kalichman L, Vered E, Volchek L. Relieving symptoms of meralgia paresthetica using Kinesio taping: a pilot study. Arch Phys Med Rehabil. 2010 Jul;91(7):1137-9. doi: 10.1016/j.apmr.2010.03.013.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2021
Primary Completion (Actual)
March 30, 2021
Study Completion (Actual)
April 23, 2021
Study Registration Dates
First Submitted
November 19, 2020
First Submitted That Met QC Criteria
November 19, 2020
First Posted (Actual)
November 25, 2020
Study Record Updates
Last Update Posted (Actual)
February 3, 2022
Last Update Submitted That Met QC Criteria
February 2, 2022
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 20/100
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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