Comparison of Different Amputation Levels

January 19, 2022 updated by: Marmara University

Comparison of Different Amputation Levels in Terms of Balance Parameters and Plantar Pressure Distribution; Lower Extremity

Lower limb amputation is a factor that changes the individual's weight transfer, gait pattern, and trunk balance. This change plantar pressure distribution of both side and cause a series of problems to be exposed over time according to level of amputation. The aim of this study is to reveal the relationship between amputation level-postural balance and amputation level-plantar pressure distribution.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

85

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, 34000
        • Marmara 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 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Unilateral transtibial and transfemoral amputees

Description

Inclusion Criteria:

  • Being unilateral transfemoral or transtibial amputee
  • Have the level of perception to understand and apply the commands given
  • Having sedantary life styles

Exclusion Criteria:

  • Having a neurological or orthopedic disorder that may affect standing posture and balance
  • The presence of pain that can affect standing posture and balance
  • Visual impairment that impairs the gait pattern and balance

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
Unilateral transtibial amputee
Other: Bipedal with open eyes
Standing bipedal with open eyes on force platform
Other: Bipedal with closed eyes
Standing bipedal with closed eyes on force platform
Other: Bipedal with open eyes and with platform
Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform
Other: Bipedal with closed eyes and with platform
Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform
Group 2
Unilateral transfemoral amputee
Other: Bipedal with open eyes
Standing bipedal with open eyes on force platform
Other: Bipedal with closed eyes
Standing bipedal with closed eyes on force platform
Other: Bipedal with open eyes and with platform
Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform
Other: Bipedal with closed eyes and with platform
Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of plantar pressure distrubution
Time Frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes
Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Measurement of plantar pressure distrubution
Time Frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel
Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Determination of center of pressure
Time Frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with open eyes
Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure
Time Frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with platform under heel.
Change from baseline center of pressure at second 10, second 20 and second 30.
Measurement of plantar pressure distrubution
Time Frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes
Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Measurement of plantar pressure distrubution
Time Frame: Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Plantar pressure distrubution (mmHg/N) will be measured by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel
Change from baseline plantar pressure distrubution at second 10, second 20 and second 30.
Determination of center of pressure
Time Frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal with closed eyes
Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure
Time Frame: Change from baseline center of pressure at second 10, second 20 and second 30.
Determination of center of pressure (cm) will be provided by force platform (F-Scan 6.70 TekScan, Boston, MA) on bipedal without platform under heel.
Change from baseline center of pressure at second 10, second 20 and second 30.

Collaborators and Investigators

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

Sponsor

Marmara University

Investigators

  • Study Director: yasar tatar, Marmara University

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)

October 1, 2019

Primary Completion (Actual)

February 10, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09.2019.357

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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