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

• ClinicalTrials.gov Identifier: NCT04644991
• Recruitment Status: Completed
• First Posted: November 25, 2020
• Last Update Posted: February 3, 2022
• Sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• Information provided by (Responsible Party): Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Transfemoral Amputees; Kinesiology Taping	Other: Kinesiology taping; Other: Six minutes walking test; Other: Shame Kinesiology Tape	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: The Investigation of the Effect of Kinesiology Taping on Lumbar Region Structures and Balance in Transfemoral Amputees
• Actual Study Start Date: March 1, 2021
• Actual Primary Completion Date: March 30, 2021
• Actual Study Completion Date: April 23, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Kinesiotape; Experimental group consisting of transfemoral amputees who kinesiology tape will be applied	Other: Kinesiology taping; Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.; Other: Six minutes walking test; Participants will be asked to walk as fast as they can for 6 minutes.
Sham Comparator: ShamKinesiotape; The placebo group of transfemoral amputees who shame kinesiology tape will be applied	Other: Six minutes walking test; Participants will be asked to walk as fast as they can for 6 minutes.; Other: Shame Kinesiology Tape; Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.

Outcome Measures

Primary Outcome Measures :

1. 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. ]
   The center of gravity displacement (cm2) will be measured at standing position on force platform during 30sn
2. 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. ]
   Stiffness of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).
3. 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 ]
   Creep value of throcalumbar fascia will be measured using a myometer (MyotonPro, Myoton AS, Tallinn, Estonia).

Secondary Outcome Measures :

1. 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. ]
   Low back pain will be measured by Visual Analog Scale between 0 (no pain) and 10 (the most severe pain)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Istanbul Saglık Bilimleri University

Istanbul, Turkey

Sponsors and Collaborators

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

More Information

Publications of Results:

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.

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. Review.

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.

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.

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.

• Responsible Party: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
• ClinicalTrials.gov Identifier: NCT04644991
• Other Study ID Numbers: 20/100
• First Posted: November 25, 2020
• Last Update Posted: February 3, 2022
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey:

amputation, transfemoral, thoracolumbal fascia, kinesiotape