Comparison of Transfemoral Amputees in Different Prosthesis Use Periods

January 8, 2025 updated by: Mustafa Sarı, Lokman Hekim Üniversitesi

Comparison of Posture, Balance, Gait and Plantar Pressure Parameters of Transfemoral Amputees in Different Prosthesis Use Periods

Nowadays, the use of prostheses is recognised as a critical rehabilitation tool for individuals who have experienced limb loss as a result of amputation in order to improve their quality of life and help them return to their activities of daily living. Prostheses offer the potential to help these individuals regain their mobility as well as optimise their physical function. Especially for unilateral transfemoral amputees, there are a number of physical challenges they face during prosthesis use. These challenges can manifest as posture, balance and weight transfer problems that prosthesis users face in their daily lives. Correcting trunk posture, increasing the ability to maintain static balance and optimising plantar load distribution are critical factors affecting the success of prosthesis use. These challenges faced by unilateral transfemoral amputees during prosthesis use are closely related to post-amputation biomechanical changes. These changes can often lead to problems with balance, gait and functionality during activities of daily living. There is no effective comparative study based on computerised analysis data on posture assessment, static balance and plantar pressure distribution of transfemoral amputees.The aim of this study was to investigate the effects of prosthesis use by comparing posture, balance, gait and plantar pressure parameters of unilateral transfemoral amputees at different prosthesis use periods

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

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
    • Sogutozu
      • Ankara, Sogutozu, Turkey, 06530
        • Lokman Hekim 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Volunteer transfemoral amputees and healthy adults

Description

Inclusion Criteria:

  • To be using unilateral hydraulic knee joint and carbon foot prosthesis.
  • Being amputee at the transfemoral level
  • Being new or using prosthesis for at least 3 years.
  • Having undergone amputation due to trauma.
  • To have completed prosthetic period rehabilitation.
  • To be between the ages of 18-45

Exclusion Criteria:

  • Having a wound-ulcer problem
  • Having amputation due to diabetes, peripheral arterial disease, tumour or venous insufficiency
  • Being diagnosed with any systemic or neurological disease
  • Affected perception and cognition
  • Body mass index above 30.
  • Having lower extremity contracture

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Transfemoral amputee group using prosthesis for at least 3 years
Diagnostic test: plantar pressure, gait and static balance analysis
Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.
Diagnostic test: trunk posture analysis
Trunk posture analysis was performed using Diers Formetric 4D.
New transfemoral amputee group using prosthesis between two and six weeks
Diagnostic test: plantar pressure, gait and static balance analysis
Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.
Diagnostic test: trunk posture analysis
Trunk posture analysis was performed using Diers Formetric 4D.
Healthy adult group
Diagnostic test: plantar pressure, gait and static balance analysis
Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.
Diagnostic test: trunk posture analysis
Trunk posture analysis was performed using Diers Formetric 4D.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plantar pressure analysis
Time Frame: Baseline
It was evaluated using the insoles of the Ultium Insole SmartLead. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It is also capable of providing users with zoned and total normalised load-time curves. In addition, it provides users with data such as 3D pressure animations and pressure centre, enabling a more detailed analysis of load distribution. These features make load distribution analysis for clinical or research purposes more effective and user-friendly. It also provides the possibility to monitor relative load distribution during balancing and bilateral or unilateral exercise applications. Applications of this technology include static and dynamic load imbalance detection, and body sway analysis.
Baseline
Gait analysis
Time Frame: Baseline
Duration-distance characteristics of gait were evaluated using Ultium Insole SmartLead insoles. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It enables contact detection and quantitative analysis in walking, running and other dynamic activities. Applications of this technology include gait analysis, and running analysis.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Trunk posture analysis
Time Frame: Baseline
Evaluated with the DIERS Formetric 4D Analysis System. The system offers the ability to perform fast and radiation-free static and dynamic (functional) optical measurements of the human spine. This system works without contact and can objectively analyse spinal posture, scoliosis and other spinal deformities with various clinical parameters.
Baseline
Fear of falling
Time Frame: Baseline
It was assessed with the International Falls Efficacy Scale (FES-I): Fear of falling can reduce a person's quality of life and lead to a range of negative consequences, including psychological distress, increased medication use, activity limitations, decreased physical functioning, increased risk of falls, and the need for institutional care. The FES measures confidence in performing activities of daily living without falling. This scale has an excellent performance in terms of reliability and is correlated with balance and gait measures. It is also known for its ability to predict future falls and decline in functional capacity. The FES-I is a scale used to assess fear of falling and was developed as an international version of the Falls Efficacy Scale. The FES-I is used to assess individuals' fear of falling and their confidence in performing daily activities. The FES-I is frequently used by health professionals to determine fear of falling and to assess the need for intervention.
Baseline
Body image
Time Frame: Baseline
It was evaluated with the Amputee Body Image Scale (ABIS). The scale is recognised as an important tool in the process of understanding and improving the body image of amputees. It was developed to assess the body experiences of amputees. The ABIS contains 20 items and measures the perceptions and feelings of the person about his/her body after amputation. During its development, important psychometric properties such as content validity, internal consistency and validity were found acceptable.
Baseline
Satisfaction level
Time Frame: Baseline
It was evaluated with the Prosthesis Satisfaction Questionnaire. This questionnaire assesses the satisfaction of amputees with their prostheses. The questionnaire consists of 15 questions, and for each question, the participants tick one of the following options: 3: completely agree, 2: strongly agree, 1: disagree, 0: strongly disagree and receive the appropriate score. The total score ranges from 0 to 45, with higher scores indicating higher levels of satisfaction.
Baseline

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Lokman Hekim Üniversitesi

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023187

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings