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

NCT04644991 | Completed

• 1 other identifier: 20/100
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transfemoral Amputees; Kinesiology Taping

Keywords

amputation, transfemoral, thoracolumbal fascia, kinesiotape

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (1)

• Low back 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.

Study Arms (2)

Kinesiotape

EXPERIMENTAL

Experimental group consisting of transfemoral amputees who kinesiology tape will be applied

Other: Kinesiology taping; Other: Six minutes walking test

ShamKinesiotape

SHAM COMPARATOR

The placebo group of transfemoral amputees who shame kinesiology tape will be applied

Other: Six minutes walking test; Other: Shame Kinesiology Tape

Interventions

Kinesiology taping OTHER

Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.

Kinesiotape

Six minutes walking test OTHER

Participants will be asked to walk as fast as they can for 6 minutes.

Kinesiotape; ShamKinesiotape

Shame Kinesiology Tape OTHER

Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.

ShamKinesiotape

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Being between the ages of 18-60
• Having unilateral transfemoral amputation
• Using prosthesis for at least 6 months
• Good prosthesis comfort

You may not qualify if:

• 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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related 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. doi: 10.1682/jrrd.2006.11.0147.

  PMID: 18566923 RESULT

• 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.

  PMID: 20647781 RESULT

• 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). 2017 Nov;49:64-71. doi: 10.1016/j.clinbiomech.2017.08.010. Epub 2017 Aug 30.

  PMID: 28888109 RESULT

• 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.

  PMID: 22630613 RESULT

• 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.

  PMID: 1590057 RESULT

• 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.

  PMID: 21589701 RESULT

• 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.

  PMID: 20537313 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 25, 2020
• Study Start: March 1, 2021
• Primary Completion: March 30, 2021
• Study Completion: April 23, 2021
• Last Updated: February 3, 2022

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)