NCT04456244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 3, 2021

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2021

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
Last Updated

January 20, 2022

Status Verified

June 1, 2020

Enrollment Period

20 days

First QC Date

June 29, 2020

Last Update Submit

January 19, 2022

Conditions

Amputation; Traumatic, LimbPostural; Defect

Keywords

amputation, postural adaptations, transtibial, transfemoral

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Group 1:Transtibial Amputation

Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.

Other: Evaluation of the static posture

Group 2:Transfemoral Amputation

Photographs will be taken with posturography device during free posture and equal weighting on both extremities. Static postural adaptations will be determined by photo analysis.

Other: Evaluation of the static posture

Interventions

Evaluation of the static postureOTHER

Photographing from the back, front and side with ADIBAS posturography in standing position

Group 1:Transtibial AmputationGroup 2:Transfemoral Amputation

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsWith Unilateral Transfemoral and Transtibial Amputation Patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

With Unilateral Transfemoral and Transtibial Amputation Patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Saglık Bilimleri University

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 18514526RESULT

  • 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.

    PMID: 23391751RESULT

  • 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: 18566923RESULT

  • 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.

    PMID: 25003278RESULT

  • 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.

    PMID: 15704512RESULT

  • 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.

    PMID: 20169280RESULT

  • 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.

    PMID: 20678938RESULT

  • 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.

    PMID: 29306147RESULT

  • 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.

    PMID: 16357788RESULT

  • 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.

    PMID: 26979898RESULT

Study Officials

  • Nilüfer Kablan, PhD

    Istanbul Sağlık Bilimleri Üniversitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 2, 2020

Study Start

January 3, 2021

Primary Completion

January 23, 2021

Study Completion

January 30, 2021

Last Updated

January 20, 2022

Record last verified: 2020-06

Locations

TU(1)