AmputationNCT05301270
The Dynamic Postural Changes in Transtibial and Transfemoral Amputees
An observational study of Amputation and EMG, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, EMG, Balance
- What is being tested?
- EMG Evaluation
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2023to 24 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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,
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Amputation, EMG, Balance, Perturbation
- Being tested
- EMG Evaluation
- Keywords
- Transtibial amputee, Transfemoral amputee, EMG, Balance, Perturbation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG EvaluationDiagnostic test
Also called Balance Assessment, Analysis Method with Video Recording
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: EMG Evaluation | |
| 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. Receives: Diagnostic Test: EMG Evaluation | |
| Healthy Subjects | Healthy individuals between the ages of 18-45 will be included. Receives: Diagnostic Test: EMG Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activations
Evaluation of muscle activations of lower extremity and trunk muscles with sEMG
Measured: Day 0
Percent Maximum Voluntary İsometric Contraction (MVIC)
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.
Measured: Day 0
Analysis with video recording
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.
Measured: Day 0
Balance Assessment
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).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start24 Feb 2023
- Primary completion24 Aug 2024
- Study completion24 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Cem TÜRKMEN, Hacettepe University
- Investigators
- Semra Topuz, Prof, Principal investigator, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301270
- Sponsor's protocol ID
- GO 21/1105
- Status last verified
- Sep 2025
- First submitted
- 18 Mar 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dynamic Postural Changes on Muscle Activation, Kinematic Parameters and Investigation of Balance Strategies in Transtibial and Transfemoral Amputees
- ClinicalTrials.gov ID
- NCT05301270
- Acronym / sponsor ID
- GO 21/1105
- Conditions
- Amputation, EMG, Balance, Perturbation
- Keywords
- Transtibial amputee, Transfemoral amputee, EMG, Balance, Perturbation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 24 Aug 2024 (actual)
- Study completion
- 24 Aug 2024 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transtibial Amputees | – | Diagnostic Test: EMG EvaluationIndividuals 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. |
| Transfemoral Amputees | – | Diagnostic Test: EMG EvaluationIndividuals 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. |
| Healthy Subjects | – | Diagnostic Test: EMG EvaluationHealthy individuals between the ages of 18-45 will be included. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG EvaluationAlso: Balance Assessment, Analysis Method with Video RecordingMuscle 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. | Diagnostic test | Healthy Subjects, Transfemoral Amputees, Transtibial Amputees |
Primary outcome
Muscle activations
Time frame: Day 0
Evaluation of muscle activations of lower extremity and trunk muscles with sEMG
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Semra Topuz, Prof principal investigator
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and EMG, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle activations (time frame: Day 0). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.