AmputationNCT07203235
The Investigations of Core Muscles, Gait, Balance and Proprioception in Transtibial Amputees
An observational study of Amputation, run by sevilay seda bas at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the effects of transtibial amputation on core function and endurance, and their relationship with proprioception, balance, and gait in adults with transtibial amputation and healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- evaluation
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Sep 2025to 30 Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cross-sectional study will be conducted at Ankara Yıldırım Beyazıt University and at private prosthetics and orthotics centers in Ankara, Turkey.
Who may be able to join
- Age between 18 and 50 years
- Unilateral transtibial amputation
- Use of a prosthesis for at least 6 months
- Medicare Functional Classification Level (MFCL) of K2 or higher (indicating the ability to ambulate in the community)
- Willingness to participate and provide informed consent
- Age between 18 and 50 years
- Willingness to participate and provide informed consent
Who cannot join
- Presence of any neurological disorder
- Presence of any mental health disorder
- Any orthopedic condition (other than amputation) within the past 12 months
- Pregnancy
- Use of a walking aid (e.g., cane, walker)
- Presence of any neurological disorder
Show all 10Show fewer
- Presence of any mental health disorder
- Any orthopedic condition within the past 12 months
- Pregnancy
- Use of a walking aid (e.g., cane, walker)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University, Department of Physiotherapy and Rehabilitation
Ankara
About this study
Official title: Investigations of The Relationship Between Core Function Aand Endurance, Gait Speed, Balance, and Proprioception in Transtibial Amputees
The goal of this observational study is to investigate the effects of transtibial amputation on core function and endurance, and their relationship with proprioception, balance, and gait in adults with transtibial amputation and healthy controls.
The main questions it aims to answer are:
Read more
Do individuals with transtibial amputation show reduced core function and endurance compared to non-amputees?
Is there a relationship between core function/endurance and proprioception, balance, and gait performance in transtibial amputees?
Researchers will compare individuals with transtibial amputation to non-amputee individuals to see if there are significant differences in core endurance, posture, and functional abilities.
Participants will:
Perform tests to assess core function and muscular endurance
Undergo evaluations of proprioception, balance, and gait
- Conditions
- Amputation
- Being tested
- evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evaluationOther
Participants will undergo a series of evaluations including core muscle function tests, endurance assessments, proprioceptive measurements, balance testing, and gait analysis. These assessments are non-invasive and observational, aimed at comparing functional performance between individuals with transtibial amputation and healthy controls. No interventions will be applied; only assessments will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Amputee Group | This group consists of individuals aged between 18 and 50 years who have undergone a unilateral transtibial amputation and have been using a prosthesis for at least 6 months. Participants must have a Medicare Functional Classification Level (MFCL) of K2 or higher, indicating the ability to ambulate in the community. Individuals with neurological or mental disorders, recent (past 12 months) orthopedic problems other than amputation, pregnancy, or those who use walking aids will be excluded. Receives: Other: evaluation | |
| Control Group | This group includes healthy individuals aged between 18 and 50 years with no history of amputation. Participants must not have any neurological or mental disorders, recent orthopedic issues (within the past 12 months), or pregnancy, and must not use walking aids. Receives: Other: evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Joint Position Sense (Proprioception)
Position sense of the knee joints in both amputated and intact limbs will be measured using a dual digital inclinometer (ACUMAR™, Lafayette, USA). Participants are instructed and trained before testing. The participant was asked to lie prone with the knee positioned at 40 degrees. After learning this angle, the participant was asked to reproduce the remembered angle independently. The difference between the target angle and the reproduced angle was recorded. This procedure was repeated three times.
Measured: Single assessment at time of participant enrollment
Secondary outcomes (7)
Trunk Position Sense (Proprioception)
Position sense of the trunk will be measured using a dual digital inclinometer (ACUMAR™, Lafayette, USA). Tests are conducted barefoot on a firm surface with eyes closed. Participants are instructed and trained before testing. For trunk position sense, inclinometers are placed on T1 and S1 spinous processes, and participants perform 30-degree trunk flexion movements and then return to neutral, attempting to replicate the angle three times.
Measured: Single assessment at time of participant enrollment
Core Muscle Function
Core muscle function will be assessed by measuring transversus abdominis (TrA) muscle strength using the Stabilizer Pressure Biofeedback Unit (Chattanooga Group Inc, USA). Participants lie prone with pressure set at 70 mmHg and perform the abdominal drawing-in maneuver three times for 10 seconds each; the average pressure change is recorded.
Measured: Single assessment at time of participant enrollment
Core Muscle Endurance (Trunk Flexor)
Core muscle endurance will be evaluated through McGill's endurance tests including trunk flexor, trunk extensor, and lateral plank tests. The trunk flexor test involves maintaining a 55-degree flexion position until the participant can no longer hold it. For all tests, participants will be asked to maintain the position for as long as possible, and the duration will be recorded.
Measured: Single assessment at time of participant enrollment
Core Muscle Endurance (Trunk Extansor)
Core muscle endurance will be evaluated through McGill's endurance tests including trunk flexor, trunk extensor, and lateral plank tests. The trunk extensor test is performed prone with pelvis, hips, and knees stabilized; participants hold a horizontal position until failure. For all tests, participants will be asked to maintain the position for as long as possible, and the duration will be recorded.
Measured: Single assessment at time of participant enrollment
Core Muscle Endurance (Lateral Plank)
Core muscle endurance will be evaluated through McGill's endurance tests including trunk flexor, trunk extensor, and lateral plank tests. The lateral plank test requires participants to maintain a side-lying plank position with the body aligned until loss of form or contact with the ground. For all tests, participants will be asked to maintain the position for as long as possible, and the duration will be recorded.
Measured: Single assessment at time of participant enrollment
Balance
Static balance will be evaluated using the single-leg stance test. Participants are asked to stand unsupported on one leg while maintaining balance. The duration they can hold this position is measured with a stopwatch and recorded in seconds
Measured: Single assessment at time of participant enrollment
Gait Speed
Gait speed will be assessed using the 10-meter walk test. Participants start from a standing position and walk 10 meters at their comfortable walking speed. The time to complete the 10 meters is measured with a stopwatch.
Measured: Single assessment at time of participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start29 Sep 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
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
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- sevilay seda bas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, sevilay seda bas, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203235
- Sponsor's protocol ID
- 08/932
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of The Relationship Between Core Function Aand Endurance, Gait Speed, Balance, and Proprioception in Transtibial Amputees
- ClinicalTrials.gov ID
- NCT07203235
- Acronym / sponsor ID
- 08/932
- Conditions
- Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- sevilay seda basUniversity, hospital or other
- Study start
- 29 Sep 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 2 Oct 2025 (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.
The goal of this observational study is to investigate the effects of transtibial amputation on core function and endurance, and their relationship with proprioception, balance, and gait in adults with transtibial amputation and healthy controls.
The main questions it aims to answer are:
Do individuals with transtibial amputation show reduced core function and endurance compared to non-amputees?
Is there a relationship between core function/endurance and proprioception, balance, and gait performance in transtibial amputees?
Researchers will compare individuals with transtibial amputation to non-amputee individuals to see if there are significant differences in core endurance, posture, and functional abilities.
Participants will:
Perform tests to assess core function and muscular endurance
Undergo evaluations of proprioception, balance, and gait
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amputee Group | – | Other: evaluationThis group consists of individuals aged between 18 and 50 years who have undergone a unilateral transtibial amputation and have been using a prosthesis for at least 6 months. Participants must have a Medicare Functional Classification Level (MFCL) of K2 or higher, indicating the ability to ambulate in the community. Individuals with neurological or mental disorders, recent (past 12 months) orthopedic problems other than amputation, pregnancy, or those who use walking aids will be excluded. |
| Control Group | – | Other: evaluationThis group includes healthy individuals aged between 18 and 50 years with no history of amputation. Participants must not have any neurological or mental disorders, recent orthopedic issues (within the past 12 months), or pregnancy, and must not use walking aids. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study will be conducted at Ankara Yıldırım Beyazıt University and at private prosthetics and orthotics centers in Ankara, Turkey.
Key inclusion criteria (7 listed)
- Age between 18 and 50 years
- Unilateral transtibial amputation
- Use of a prosthesis for at least 6 months
- Medicare Functional Classification Level (MFCL) of K2 or higher (indicating the ability to ambulate in the community)
- Willingness to participate and provide informed consent
Key exclusion criteria (10 listed)
- Presence of any neurological disorder
- Presence of any mental health disorder
- Any orthopedic condition (other than amputation) within the past 12 months
- Pregnancy
- Use of a walking aid (e.g., cane, walker)
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 |
|---|---|---|
| evaluationParticipants will undergo a series of evaluations including core muscle function tests, endurance assessments, proprioceptive measurements, balance testing, and gait analysis. These assessments are non-invasive and observational, aimed at comparing functional performance between individuals with transtibial amputation and healthy controls. No interventions will be applied; only assessments will be conducted. | Other | Amputee Group, Control Group |
Primary outcome
Knee Joint Position Sense (Proprioception)
Time frame: Single assessment at time of participant enrollment
Position sense of the knee joints in both amputated and intact limbs will be measured using a dual digital inclinometer (ACUMAR™, Lafayette, USA). Participants are instructed and trained before testing. The participant was asked to lie prone with the knee positioned at 40 degrees. After learning this angle, the participant was asked to reproduce the remembered angle independently. The difference between the target angle and the reproduced angle was recorded. This procedure was repeated three times.
7 secondary outcomes
Trunk Position Sense (Proprioception)
Time frame: Single assessment at time of participant enrollment
Core Muscle Function
Time frame: Single assessment at time of participant enrollment
Core Muscle Endurance (Trunk Flexor)
Time frame: Single assessment at time of participant enrollment
Core Muscle Endurance (Trunk Extansor)
Time frame: Single assessment at time of participant enrollment
Core Muscle Endurance (Lateral Plank)
Time frame: Single assessment at time of participant enrollment
Balance
Time frame: Single assessment at time of participant enrollment
Gait Speed
Time frame: Single assessment at time of participant enrollment
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 7 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by sevilay seda bas 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 7 inclusion and 10 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 7 Jan 2026. 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?
Knee Joint Position Sense (Proprioception) (time frame: Single assessment at time of participant enrollment). 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 7 Jan 2026.