Comparison of Transtibial and Transfemoral Amputees' Posture Parameters

NCT ID: NCT04456244

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-03

Study Completion Date

2021-01-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amputation; Traumatic, Limb Postural; Defect

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Evaluation of the static posture

Intervention Type OTHER

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

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.

Evaluation of the static posture

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Evaluation of the static posture

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role collaborator

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nilüfer Kablan, PhD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Sağlık Bilimleri Üniversitesi

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Saglık Bilimleri University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 18514526 (View on PubMed)

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.

Reference Type RESULT
PMID: 23391751 (View on PubMed)

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.

Reference Type RESULT
PMID: 18566923 (View on PubMed)

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.

Reference Type RESULT
PMID: 25003278 (View on PubMed)

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.

Reference Type RESULT
PMID: 15704512 (View on PubMed)

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.

Reference Type RESULT
PMID: 20169280 (View on PubMed)

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.

Reference Type RESULT
PMID: 20678938 (View on PubMed)

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.

Reference Type RESULT
PMID: 29306147 (View on PubMed)

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.

Reference Type RESULT
PMID: 16357788 (View on PubMed)

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.

Reference Type RESULT
PMID: 26979898 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

19/164

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.