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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04644991
Other study ID # 20/100
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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.
See also
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Completed NCT02346019 - Thigh Reduction Surgery of Above Knee Amputee Residual Limbs to Improve Prosthesis Fit and Patient Outcomes N/A