Comparison of Transtibial and Transfemoral Amputees' Posture Parameters

Postural; Defect Clinical Trial

Official title:

Comparison of Transtibial and Transfemoral Amputees' Posture Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456244
• Other study ID #: 19/164
• Status: Completed
• Start date: January 3, 2021
• Est. completion date: January 30, 2021

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 30, 2021
• Est. primary completion date: January 23, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amputation, Traumatic
• Amputation; Traumatic, Limb
• Postural; Defect

Intervention

Other:
• Evaluation of the static posture
Photographing from the back, front and side with ADIBAS posturography in standing position

Locations

Country	Name	City	State
Turkey	Istanbul Saglik Bilimleri University	Istanbul

Sponsors (2)

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

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Molina-Rueda F, Alguacil-Diego IM, Cuesta-Gómez A, Iglesias-Giménez J, Martín-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. — View 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 — View Citation

Soares AS, Yamaguti EY, Mochizuki L, Amadio AC, Serrão JC. Biomechanical parameters of gait among transtibial amputees: a review. Sao Paulo Med J. 2009 Sep;127(5):302-9. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the static posture-1	Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in free standing position	Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Primary	Evaluation of the static posture-2	Photographing from the back, front and side with posturography (ADIBAS Posture, 1520, Kinect for XBOX ONE) in equal weighting on platform (3D L.A.S.A.R. Posture, 743L500, Ottobock)	Changes from baseline static posture adaptations before and following Six Minutes Walking Test
Primary	Evaluation of the back pain	Pain will be evaluated by using Visual Analog Scale ranging 0(no pain)-10(worst pain)	Changes from baseline static posture adaptations before and following Six Minutes Walking Test