The Dynamic Postural Changes in Transtibial and Transfemoral Amputees

September 9, 2025 updated by: Mustafa Cem TÜRKMEN, Hacettepe University

The Effect of Dynamic Postural Changes on Muscle Activation, Kinematic Parameters and Investigation of Balance Strategies in Transtibial and Transfemoral Amputees

This research was planned to examine how unpredictable movements on the support surface will affect muscle activation and kinematic parameters in individuals with transtibial and transfemoral amputations. Individuals aged between 18-45 years, using prostheses for at least 1 year, able to stand and walk independently without a walking aid, and volunteered to participate in the study with unilateral transtibial and unilateral transfemoral amputation, and healthy individuals similar to these individuals in terms of age and gender will be included in the study.

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.

Detailed Description

This research was planned to examine how unpredictable movements on the support surface will affect muscle activation and kinematic parameters in individuals with transtibial and transfemoral amputations. Individuals aged between 18-45 years, using prostheses for at least 1 year, able to stand and walk independently without a walking aid, and volunteered to participate in the study with unilateral transtibial and unilateral transfemoral amputation, and healthy individuals similar to these individuals in terms of age and gender will be included in the study. The number of cases considered to be included in the study will be determined by the number of individuals required for the power of the study to be 0.80 in the interim statistical analysis to be made after including 5 individuals, since no similar studies on the subject could be found. After determining the number of individuals to be included in the study group, a control group consisting of the same number of healthy individuals will be formed. The amount of body weight on the intact leg and prosthetic limb of individuals with amputation "L.A.S.A.R." with the posture device, artificial limb (prosthesis) awareness will be evaluated with the "Forgotten Joint Score-12" scale. Posture assessment of all individuals will be carried out by photogrammetric method. Dynamic balance evaluations of all participants will be made with the "Bertec balance device". Afterwards, the compensatory postural responses of all individuals, which are formed by the movements of the platform in the sagittal plane at an unpredictable moment, while standing on the motor-assisted and controllable movable platform, will be evaluated. Muscle activations occurring in both lower extremity and trunk muscles during compensatory postural responses will be evaluated with the "Delsys Trigno IM wireless surface electromyography (sEMG) system". Simultaneously, the motion will be recorded with the camera from the sagittal plane and the "Dartfish Analysis Software" software will be used for the analysis of the video images obtained. By using video recording and analysis method, angular changes in the joints during body oscillations, segment positions and balance strategies used will be examined. As a result of our research, it is anticipated to determine whether there is a difference between transtibial, transfemoral amputation and healthy individuals in terms of balance strategies resulting from unexpected surface perturbations, muscle activations in the lower extremities and trunk, and kinematic changes. In addition, it is anticipated to determine whether there is a relationship between dynamic balance values and lower extremity and trunk muscle activations that occur with unexpected surface perturbations in transtibial amputated, transfemoral amputated and healthy individuals. Thus, it is thought that the biomechanical properties of compensatory postural responses, which are very important in terms of maintaining postural control in individuals with transtibial amputation and transfemoral amputation, will contribute to the current scientific knowledge.

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.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

14 years to 41 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Individuals with amputation to be included in the study (study group); It will consist of individuals who agree to participate in the research with transtibial or transfemoral amputation followed at Hacettepe University Faculty of Physical Therapy and Rehabilitation, Prosthesis and Biomechanics Unit and Bilim Orthotics Prosthesis Application Center.

The control group, on the other hand, will consist of volunteers from patients' relatives and employees at Hacettepe University Faculty of Physical Therapy and Rehabilitation and Bilim Orthotics Prosthesis Application Center, who are similar to the study group in terms of age and gender.

Description

Inclusion Criteria:

For all groups;

  • After giving detailed information about the research, those who volunteered to participate in the research
  • Able to stand and walk independently without any walking aid
  • They are determined as individuals with cooperation who can understand tests and evaluations.

For Amputation Groups;

  • Having unilateral transtibial or transfemoral amputation,
  • The cause of amputation is traumatic,
  • Functional classification is at the level of K2 and K3 (Medicare Functional Classification Level),
  • Using prosthesis for at least 1 year,
  • No skin lesion or open wound on the stump,
  • No phantom sensation or pain
  • It was determined as individuals who do not have musculoskeletal problems (muscle shortness, limitation of joint movement, etc.) that may affect balance other than amputation.

Exclusion Criteria:

For all groups;

  • Known orthopedic (except amputation for the amputee group), neurological disease, vestibular problems, severe visual impairment, cognitive dysfunction,
  • Having pain originating from the musculoskeletal system (Also for the amputation group; stump pain or the presence of pain caused by the use of prosthesis),
  • Individuals who exercise regularly,
  • With a history of serious trauma,
  • History of falling in the last 1 year,
  • Pain during measurement of maximal voluntary contraction,
  • It was determined as individuals with a body mass index (BMI)>30 kg/m².

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: Prospective

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.
Transtibial Amputees
Individuals aged 18-45 years, with unilateral transtibial amputation, traumatic amputation cause, using prosthesis for at least 1 year, no skin lesions-open wound on the stump, no phantom sensation or pain, no musculoskeletal problems that may affect balance other than amputation will be included.
Diagnostic test: EMG Evaluation
Muscle activations in the lower extremity and trunk muscles during compensatory postural responses will be evaluated. The Delsys Trigno IM (Delsys Inc. Natick, Massachusetts, USA) wireless surface electromyography (EMG) system will be used to evaluate muscle activation. In the lower extremity; Muscle activations of tibialis anterior, gastrocnemius, quadriceps and hamstring muscle groups and erector spinae in the trunk will be evaluated. While the muscle groups above the stump on the amputated side of the individuals in the amputation group will be evaluated, all muscle groups specified on the healthy side will be evaluated. In the control group, all muscle groups on the dominant side, but on the non-dominant side, all other muscles except the tibialis anterior and gastrocnemius muscles will be evaluated in order to be compatible with the amputation group.
Other Names:
  • Balance Assessment
  • Analysis Method with Video Recording
Transfemoral Amputees
Individuals aged 18-45 years, with unilateral transfemoral amputation, traumatic amputation cause, using prosthesis for at least 1 year, no skin lesions-open wound on the stump, no phantom sensation or pain, no musculoskeletal problems that may affect balance other than amputation will be included.
Diagnostic test: EMG Evaluation
Muscle activations in the lower extremity and trunk muscles during compensatory postural responses will be evaluated. The Delsys Trigno IM (Delsys Inc. Natick, Massachusetts, USA) wireless surface electromyography (EMG) system will be used to evaluate muscle activation. In the lower extremity; Muscle activations of tibialis anterior, gastrocnemius, quadriceps and hamstring muscle groups and erector spinae in the trunk will be evaluated. While the muscle groups above the stump on the amputated side of the individuals in the amputation group will be evaluated, all muscle groups specified on the healthy side will be evaluated. In the control group, all muscle groups on the dominant side, but on the non-dominant side, all other muscles except the tibialis anterior and gastrocnemius muscles will be evaluated in order to be compatible with the amputation group.
Other Names:
  • Balance Assessment
  • Analysis Method with Video Recording
Healthy Subjects
Healthy individuals between the ages of 18-45 will be included.
Diagnostic test: EMG Evaluation
Muscle activations in the lower extremity and trunk muscles during compensatory postural responses will be evaluated. The Delsys Trigno IM (Delsys Inc. Natick, Massachusetts, USA) wireless surface electromyography (EMG) system will be used to evaluate muscle activation. In the lower extremity; Muscle activations of tibialis anterior, gastrocnemius, quadriceps and hamstring muscle groups and erector spinae in the trunk will be evaluated. While the muscle groups above the stump on the amputated side of the individuals in the amputation group will be evaluated, all muscle groups specified on the healthy side will be evaluated. In the control group, all muscle groups on the dominant side, but on the non-dominant side, all other muscles except the tibialis anterior and gastrocnemius muscles will be evaluated in order to be compatible with the amputation group.
Other Names:
  • Balance Assessment
  • Analysis Method with Video Recording

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
Muscle activations
Time Frame: Day 0
Evaluation of muscle activations of lower extremity and trunk muscles with sEMG
Day 0
Analysis with video recording
Time Frame: Day 0
Data obtained by video recording on individuals on a platform that can move in the sagittal plane will be obtained and analyzed with Dartfish software.
Day 0
Balance Assessment
Time Frame: Day 0
Dynamic balance assessment will be performed with the Bertec BalanceCheck Screener™ BP5050 20x20 inc device (Bertec BP5050 balance plate platform; Bertec, Corp., Columbus, OH, USA).
Day 0
Percent Maximum Voluntary İsometric Contraction (MVIC)
Time Frame: Day 0
In order to normalize the muscles whose activations will be evaluated as percent MVIC, MVIC values will be measured in muscle test positions, which are the positions where the muscles are most activated.
Day 0

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.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Semra Topuz, Prof, 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)

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.
February 24, 2023

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.
August 24, 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.
August 24, 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).
March 18, 2022

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.
March 18, 2022

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 29, 2022

Study Record Updates

Last Update Posted (Estimated)

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.
September 15, 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.
September 9, 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.
September 1, 2025

More Information

Terms related to this study

Keywords

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.
  • GO 21/1105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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