Clinical trial NCT04456244: Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
Official title: Comparison of Transtibial and Transfemoral Amputees' Posture Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation; Traumatic, Limb
Postural; Defect
Keywords: amputation, postural adaptations, transtibial, transfemoral
Lead sponsor: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
Sponsor class: OTHER
Collaborators: name: Istanbul Saglik Bilimleri University
First posted: 2020-07-02
Enrollment: 29
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: With Unilateral Transfemoral and Transtibial Amputation Patients

Brief summary: With the onset of prosthesis use following lower extremity amputations, body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. The aim of this study is to determine the static postural adaptations that appear at different amputation levels.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-65
* Having had an amputation at least 6 months ago
* Have had transfemoral amputation or transtibial amputation
* To be able to perform ambulation independently

Exclusion Criteria:

* mental inability to understand commands
* have a neurological, orthopedic and systemic problem that will negatively affect posture or gait.

Primary outcomes:
measure: Evaluation of the static posture-1
timeFrame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
measure: Evaluation of the static posture-2
timeFrame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
measure: Evaluation of the back pain
timeFrame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Saglık Bilimleri University
Study officials:
affiliation: Istanbul Sağlık Bilimleri Üniversitesi
name: Nilüfer Kablan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silverman AK, Fey NP, Portillo A, Walden JG, Bosker G, Neptune RR. Compensatory mechanisms in below-knee amputee gait in response to increasing steady-state walking speeds. Gait Posture. 2008 Nov;28(4):602-9. doi: 10.1016/j.gaitpost.2008.04.005. Epub 2008 Jun 2.
citation: Hendershot BD, Nussbaum MA. Persons with lower-limb amputation have impaired trunk postural control while maintaining seated balance. Gait Posture. 2013 Jul;38(3):438-42. doi: 10.1016/j.gaitpost.2013.01.008. Epub 2013 Feb 4.
citation: 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.
citation: Molina-Rueda F, Alguacil-Diego IM, Cuesta-Gomez A, Iglesias-Gimenez J, Martin-Vivaldi A, Miangolarra-Page JC. Thorax, pelvis and hip pattern in the frontal plane during walking in unilateral transtibial amputees: biomechanical analysis. Braz J Phys Ther. 2014 May-Jun;18(3):252-8. doi: 10.1590/bjpt-rbf.2014.0032.
citation: Kulkarni J, Gaine WJ, Buckley JG, Rankine JJ, Adams J. Chronic low back pain in traumatic lower limb amputees. Clin Rehabil. 2005 Jan;19(1):81-6. doi: 10.1191/0269215505cr819oa.
citation: Soares AS, Yamaguti EY, Mochizuki L, Amadio AC, Serrao JC. Biomechanical parameters of gait among transtibial amputees: a review. Sao Paulo Med J. 2009 Sep;127(5):302-9. doi: 10.1590/s1516-31802009000500010.
citation: Lloyd CH, Stanhope SJ, Davis IS, Royer TD. Strength asymmetry and osteoarthritis risk factors in unilateral trans-tibial, amputee gait. Gait Posture. 2010 Jul;32(3):296-300. doi: 10.1016/j.gaitpost.2010.05.003. Epub 2010 Aug 1.
citation: Khamis S, Carmeli E. The effect of simulated leg length discrepancy on lower limb biomechanics during gait. Gait Posture. 2018 Mar;61:73-80. doi: 10.1016/j.gaitpost.2017.12.024. Epub 2017 Dec 28.
citation: Carmona GA, Hoffmeyer P, Herrmann FR, Vaucher J, Tschopp O, Lacraz A, Vischer UM. Major lower limb amputations in the elderly observed over ten years: the role of diabetes and peripheral arterial disease. Diabetes Metab. 2005 Nov;31(5):449-54. doi: 10.1016/s1262-3636(07)70215-x.
citation: Gaffney BM, Murray AM, Christiansen CL, Davidson BS. Identification of trunk and pelvis movement compensations in patients with transtibial amputation using angular momentum separation. Gait Posture. 2016 Mar;45:151-6. doi: 10.1016/j.gaitpost.2016.01.015. Epub 2016 Jan 25.