Sitting Balance in Lower Limb Amputees

October 11, 2023 updated by: Gökhan Karakaş, Hacettepe University

Evaluation of Sitting Balance in Lower Limb Amputees: a Case Control Study

The aim of this study is to compare the sitting and standing postural stability of transfemoral individuals with healthy individuals with similar demographic characteristics.

Study Overview

Status

Completed

Conditions

Detailed Description

Postural stability is important for amputees to perform daily life activities and participate in social activities. The aim of this study is to compare the sitting and standing stability of transfemoral individuals with healthy individuals with similar demographic characteristics. A force platform was used to measure the postural stability of individuals. The sitting limits of stability of the participants were recorded in cm. Amputees between the ages of 18-50, using their prosthesis for at least 6 months, and healthy individuals with similar demographic characteristics were included in the study. Congenital amputees, individuals with bilateral lower extremity amputations, and individuals with central or peripheral vestibular disorders were excluded. Our study will reveal the importance of sitting stability limits in the evaluation and treatment of amputees.

Study Type

Observational

Enrollment (Actual)

20

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
    • Samanpazarı
      • Ankara, Samanpazarı, Turkey, 06100
        • Hacettepe University, Faculty of Physical Therapy and Rehabilitation, Department of Physiotherapy and Rehabilitation

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.

Description

Inclusion Criteria for amputee:

  • Unilateral transfemoral amputation
  • Using their prosthesis for at least 6 months

Exclusion Criteria:

  • congenital amputee
  • Bilateral lower extremity amputation
  • Central or peripheral vestibular disorders

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
1) Experimental Group: Transfemoral Amputee
Balance assessment in sitting
2) Control Group: Healthy Subjects
Balance assessment in sitting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Limits of stability
Time Frame: 15 minutes
Limits of stability test evaluates dynamic balance of participants. Computerized balance system measured limits of stability for forward, backward, right and left side movements in sitting. It calculates the maximum distance a person can lean without losing balance. The unit of measure is centimeters. The higher value is indicated the better balance.
15 minutes

Collaborators and Investigators

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

Sponsor

Hacettepe University

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)

May 1, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

October 25, 2022

First Submitted That Met QC Criteria

October 25, 2022

First Posted (Actual)

October 28, 2022

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GO 22-385

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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