Comparison of Transtibial and Transfemoral Amputees' Posture Parameters

January 19, 2022 updated by: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

29

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • İstanbul Sağlık Bilimleri University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

With Unilateral Transfemoral and Transtibial Amputation Patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other: Evaluation of the static posture
Photographing from the back, front and side with ADIBAS posturography in standing position

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the static posture-1
Time Frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
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
Time Frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
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
Time Frame: Changes from baseline static posture adaptations before and following Six Minutes Walking Test
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Collaborators

Istanbul Saglik Bilimleri University

Investigators

  • Principal Investigator: Nilüfer Kablan, PhD, Istanbul Sağlık Bilimleri Üniversitesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2021

Primary Completion (Actual)

January 23, 2021

Study Completion (Actual)

January 30, 2021

Study Registration Dates

First Submitted

June 29, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 2, 2020

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19/164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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