The Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees

Kinesiology Taping Clinical Trial

Official title:

The Investigation of the Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04644991
• Other study ID #: 20/100
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: April 23, 2021

Study information

• Verified date: November 2020
• Source: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 23, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Kinesiology Taping
• Transfemoral Amputees

Intervention

Other:
• Kinesiology taping
Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.
• Six minutes walking test
Participants will be asked to walk as fast as they can for 6 minutes.
• Shame Kinesiology Tape
Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.

Locations

Country	Name	City	State
Turkey	Istanbul Saglik Bilimleri University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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.0b013e3181e71d — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of Postural Stability	The center of gravity displacement (cm2) will be measured at standing position on force platform during 30sn	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.
Primary	Measurement of Stiffness	Stiffness of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).	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.
Primary	Measurement of Creep	Creep value of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).	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
Secondary	Low back pain	Low back pain will be measured by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain)	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.