AmputationusgNCT07875075
Core Muscle Function and Postural Control in Lower Extremity Amputees
An observational study of Amputation and Ultrasonography, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to determine the effect of amputation on core muscle groups by comparing core muscle thickness in individuals with lower extremity amputation to both their intact side and a healthy control group using ultrasonographic assessment. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Ultrasonography, Postural Control
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Dec 2025to 4 Dec 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.
Who may be able to join
- Being between 20-60 years of age
- Having a unilateral transtibial or transfemoral amputation
- Being at K1-K3 functional activity level
- Being able to stand without the use of assistive devices
- Using a prosthesis for at least 4 hours per day
- Volunteering to participate in the study
- Healthy individuals with demographic characteristics similar to the amputee group
- Not having a regular exercise habit
Who cannot join
- Having phantom or residual limb pain ≥6 according to the Numeric Rating Scale
- Having bilateral lower extremity amputation
- Having a Body Mass Index greater than 30
- For the Healthy Control Group
- Having central or peripheral vestibular disorders
- Having lower extremity joint contractures
- Using medications that affect balance
- Having a Body Mass Index greater than 30
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dokuz Eylül University Faculty of Physical Therapy and Rehabilitation 15 July Health Campus, Mithatpaşa Street No: 56/15 İnciraltı 35340 - İZMİR
Balçova, İzmir, 35130
gökhan karakaş, M.Sc., g.karakass@gmail.com
About this study
Official title: Investigation of the Relationship Between Core Muscle Function Assessed by Ultrasonography and Postural Control During Different Activities in Individuals With Lower Extremity Amputation
The primary aim of this study is to determine the effect of amputation on core muscle groups by comparing core muscle thickness in individuals with lower extremity amputation to both their intact side and a healthy control group using ultrasonographic assessment.
The secondary aim is to investigate the relationship between core muscle thickness and postural stability outcomes during different activities in individuals with lower extremity amputation, and to determine the effect of core muscles on postural control.
Read the detailed description
This study aims to investigate the effects of lower extremity amputation on core muscles and their relationship with postural control. The primary objective is to compare core muscle thickness in individuals with lower extremity amputation with both their intact side and a healthy control group using ultrasonographic assessment. The secondary objective is to examine the relationship between core muscle thickness and postural stability during different functional activities, and to determine the role of core muscles in postural control.
It is hypothesized that there are differences in core muscle thickness between the amputated and intact sides, as well as between amputees and healthy individuals. Additionally, core muscle function is expected to be associated with postural sway, limits of stability, functional tasks (such as sit-to-stand and stair negotiation), prosthesis adaptation, fear of falling, and the percentage of limb loss.
The study sample will consist of transtibial and transfemoral amputees who attend routine follow-up visits, along with a matched healthy control group. Ultrasonography will be used to objectively assess core muscle thickness, allowing the identification of muscle atrophy and asymmetrical loading. Postural control will be evaluated using a computerized balance system during various activities.
Statistical analyses will include descriptive statistics, normality tests, group comparisons, and correlation analyses. The findings are expected to contribute to the development of targeted rehabilitation programs focusing on core muscles to improve postural stability and reduce fall risk in individuals with lower extremity amputation.
- Conditions
- Amputation, Ultrasonography, Postural Control, Balance, Core Muscles, Stiffness
- Keywords
- amputation, ultrasonography, balance, limits of stability, stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1) Experimental Group: individual with amputation | Participants in the amputee group will include individuals aged 20-60 years with unilateral transtibial or transfemoral amputation, classified as K1-K3 functional level, who are able to stand without assistive devices and use their prosthesis for at least 4 hours per day. All participants must provide voluntary informed consent. Individuals will be excluded if they have severe phantom or residual limb pain (≥6 on the Numeric Rating Scale), bilateral lower extremity amputation, or a body mass index greater than 30. | |
| Control Group: Healthy Subjects | The control group will consist of healthy individuals with demographic characteristics similar to the amputee group and without a regular exercise habit. Individuals will be excluded if they have central or peripheral vestibular disorders, lower extremity joint contractures, use medications affecting balance, or have a body mass index greater than 30. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragm Thickening Fraction
Diaphragm thickness will be assessed bilaterally at the zone of apposition using B-mode ultrasonography at the end of quiet expiration and during deep inspiration. Diaphragm thickening fraction will be calculated as [(thickness during deep inspiration - thickness at the end of quiet expiration) / thickness at the end of quiet expiration] × 100 and reported as a percentage (%). Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. Bilateral measurements will be used for side and group comparisons.
Measured: Day 1
Transversus Abdominis Activation Ratio
Transversus abdominis muscle thickness will be assessed bilaterally using B-mode ultrasonography at the end of quiet expiration at rest and during the abdominal drawing-in maneuver. The activation ratio will be calculated by dividing muscle thickness during the abdominal drawing-in maneuver by muscle thickness at rest. Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. The activation ratio is dimensionless. Bilateral measurements will be used for side and group comparisons.
Measured: Day 1
Internal Oblique Activation Ratio
Internal oblique muscle thickness will be assessed bilaterally using B-mode ultrasonography at the end of quiet expiration at rest and during the abdominal drawing-in maneuver. The activation ratio will be calculated by dividing muscle thickness during the abdominal drawing-in maneuver by muscle thickness at rest. Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. The activation ratio is dimensionless. Bilateral measurements will be used for side and group comparisons.
Measured: Day 1
Secondary outcomes (16)
Standing Postural Sway
Standing postural sway will be assessed using the Modified Clinical Test of Sensory Interaction on Balance (mCTSIB) with the NeuroCom Balance Master. Center-of-gravity sway velocity will be measured during standing under four sensory conditions: eyes open on a firm surface, eyes closed on a firm surface, eyes open on a foam surface, and eyes closed on a foam surface. Sway velocity will be expressed in degrees per second (°/s), with lower values indicating better postural stability.
Measured: Day 1
Percentage of Remaining Limb
The remaining limb length will be measured using a tape measure. The percentage of remaining limb will be calculated by dividing the remaining limb length by the total lower-extremity length and multiplying by 100. The result will be expressed as a percentage (%).
Measured: Day 1
Prosthesis Awareness
Prosthesis awareness will be assessed using the amputee-adapted Forgotten Joint Score-12 (FJS-12). The questionnaire consists of 12 items evaluating awareness of the prosthesis during activities of daily living. Higher scores indicate a greater ability to forget the prosthesis during daily activities.
Measured: Day 1
Fear of Falling
Fear of falling will be assessed using the Falls Efficacy Scale-International (FES-I). The scale consists of 16 items scored from 1 to 4, with a total score ranging from 16 to 64. Higher scores indicate greater concern about falling.
Measured: Day 1
Reaction Time During Limits of Stability Test
Reaction Time During Limits of Stability Test
Reaction time will be assessed using the Limits of Stability test of the NeuroCom Balance Master. It represents the time between the visual cue and the initiation of voluntary movement toward the target and will be reported in seconds (s).
Measured: Day 1
Movement Velocity During Limits of Stability Test
Movement velocity will be assessed using the Limits of Stability test of the NeuroCom Balance Master. It represents the average speed of center-of-gravity movement toward the target and will be reported in degrees per second (°/s).
Measured: Day 1
Endpoint Excursion During Limits of Stability Test
Endpoint excursion will be assessed using the Limits of Stability test of the NeuroCom Balance Master. It represents the distance reached by the center of gravity during the initial movement toward the target and will be reported as a percentage (%).
Measured: Day 1
Maximum Excursion During Limits of Stability Test
Maximum excursion will be assessed using the Limits of Stability test of the NeuroCom Balance Master. It represents the maximum distance reached by the center of gravity toward the target and will be reported as a percentage (%).
Measured: Day 1
Directional Control During Limits of Stability Test
Directional control will be assessed using the Limits of Stability test of the NeuroCom Balance Master. It reflects the accuracy of center-of-gravity movement toward the intended target relative to extraneous movement and will be reported as a percentage (%).
Measured: Day 1
Weight Transfer Time During Sit-to-Stand
Weight transfer time will be assessed using the Sit-to-Stand test of the NeuroCom Balance Master. It represents the time from the initiation of the test until the center of gravity is transferred over the feet and will be reported in seconds (s).
Measured: Day 1
Rising Index During Sit-to-Stand
The rising index will be assessed using the Sit-to-Stand test on the NeuroCom Balance Master. It represents the force exerted by the lower extremities on the force platform during rising, normalized to body weight, and will be reported as a percentage (%).
Measured: Day 1
Postural Sway Velocity After Sit-to-Stand
Postural sway velocity will be assessed using the Sit-to-Stand test on the NeuroCom Balance Master. It represents the center-of-gravity sway velocity during the first five seconds after rising to a standing position and will be reported in degrees per second (°/s).
Measured: Day 1
Weight-Bearing Asymmetry During Sit-to-Stand
Weight-bearing asymmetry will be assessed using the Sit-to-Stand test on the NeuroCom Balance Master. It quantifies the asymmetry in load distribution between the right and left lower extremities during the sit-to-stand task and in the first five seconds of standing, and will be reported as a percentage (%).
Measured: day 1
Lift-Up Index During the Step Up/Over Task
The lift-up index will be assessed using the Step Up/Over test on the NeuroCom Balance Master. It represents the force exerted by the stepping limb to raise the body onto the step, normalized to body weight, and will be reported as a percentage (%).
Measured: Day 1
Movement Time During the Step Up/Over Task
Movement time will be assessed using the Step Up/Over test on the NeuroCom Balance Master. It represents the time required to complete the stepping movement and will be reported in seconds (s).
Measured: day 1
Impact Index During the Step Up/Over Task
The impact index will be assessed using the Step Up/Over test on the NeuroCom Balance Master. It represents the force exerted on the force platform during landing, normalized to body weight, and will be reported as a percentage (%).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start4 Dec 2025
- Primary completion4 Jul 2027 (estimated)
- Study completion4 Dec 2027 (estimated)
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
- 32 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gökhan Karakaş, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875075
- Sponsor's protocol ID
- FTREK25/164
- Acronym
- usg
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Core Muscle Function Assessed by Ultrasonography and Postural Control During Different Activities in Individuals With Lower Extremity Amputation
- ClinicalTrials.gov ID
- NCT07875075
- Acronym / sponsor ID
- usg / FTREK25/164
- Conditions
- Amputation, Ultrasonography, Postural Control, Balance, Core Muscles, Stiffness
- Keywords
- amputation, ultrasonography, balance, limits of stability, stiffness
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 4 Jul 2027 (estimated)
- Study completion
- 4 Dec 2027 (estimated)
- First posted
- 15 Oct 2026 (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 primary aim of this study is to determine the effect of amputation on core muscle groups by comparing core muscle thickness in individuals with lower extremity amputation to both their intact side and a healthy control group using ultrasonographic assessment.
The secondary aim is to investigate the relationship between core muscle thickness and postural stability outcomes during different activities in individuals with lower extremity amputation, and to determine the effect of core muscles on postural control.
Detailed description
This study aims to investigate the effects of lower extremity amputation on core muscles and their relationship with postural control. The primary objective is to compare core muscle thickness in individuals with lower extremity amputation with both their intact side and a healthy control group using ultrasonographic assessment. The secondary objective is to examine the relationship between core muscle thickness and postural stability during different functional activities, and to determine the role of core muscles in postural control.
It is hypothesized that there are differences in core muscle thickness between the amputated and intact sides, as well as between amputees and healthy individuals. Additionally, core muscle function is expected to be associated with postural sway, limits of stability, functional tasks (such as sit-to-stand and stair negotiation), prosthesis adaptation, fear of falling, and the percentage of limb loss.
The study sample will consist of transtibial and transfemoral amputees who attend routine follow-up visits, along with a matched healthy control group. Ultrasonography will be used to objectively assess core muscle thickness, allowing the identification of muscle atrophy and asymmetrical loading. Postural control will be evaluated using a computerized balance system during various activities.
Statistical analyses will include descriptive statistics, normality tests, group comparisons, and correlation analyses. The findings are expected to contribute to the development of targeted rehabilitation programs focusing on core muscles to improve postural stability and reduce fall risk in individuals with lower extremity amputation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1) Experimental Group: individual with amputation | – | –Participants in the amputee group will include individuals aged 20-60 years with unilateral transtibial or transfemoral amputation, classified as K1-K3 functional level, who are able to stand without assistive devices and use their prosthesis for at least 4 hours per day. All participants must provide voluntary informed consent. Individuals will be excluded if they have severe phantom or residual limb pain (≥6 on the Numeric Rating Scale), bilateral lower extremity amputation, or a body mass index greater than 30. |
| Control Group: Healthy Subjects | – | –The control group will consist of healthy individuals with demographic characteristics similar to the amputee group and without a regular exercise habit. Individuals will be excluded if they have central or peripheral vestibular disorders, lower extremity joint contractures, use medications affecting balance, or have a body mass index greater than 30. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Amputees who applied to our faculty for prosthesis construction and control, and healthy individuals from relatives of the researcher reached by snowball method will constitute the sample of the study.
Key inclusion criteria (8 listed)
- Being between 20-60 years of age
- Having a unilateral transtibial or transfemoral amputation
- Being at K1-K3 functional activity level
- Being able to stand without the use of assistive devices
- Using a prosthesis for at least 4 hours per day
Key exclusion criteria (8 listed)
- Having phantom or residual limb pain ≥6 according to the Numeric Rating Scale
- Having bilateral lower extremity amputation
- Having a Body Mass Index greater than 30
- For the Healthy Control Group
- Having central or peripheral vestibular disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diaphragm Thickening Fraction
Time frame: Day 1
Diaphragm thickness will be assessed bilaterally at the zone of apposition using B-mode ultrasonography at the end of quiet expiration and during deep inspiration. Diaphragm thickening fraction will be calculated as [(thickness during deep inspiration - thickness at the end of quiet expiration) / thickness at the end of quiet expiration] × 100 and reported as a percentage (%). Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. Bilateral measurements will be used for side and group comparisons.
Transversus Abdominis Activation Ratio
Time frame: Day 1
Transversus abdominis muscle thickness will be assessed bilaterally using B-mode ultrasonography at the end of quiet expiration at rest and during the abdominal drawing-in maneuver. The activation ratio will be calculated by dividing muscle thickness during the abdominal drawing-in maneuver by muscle thickness at rest. Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. The activation ratio is dimensionless. Bilateral measurements will be used for side and group comparisons.
Internal Oblique Activation Ratio
Time frame: Day 1
Internal oblique muscle thickness will be assessed bilaterally using B-mode ultrasonography at the end of quiet expiration at rest and during the abdominal drawing-in maneuver. The activation ratio will be calculated by dividing muscle thickness during the abdominal drawing-in maneuver by muscle thickness at rest. Three high-quality measurements will be obtained for each side, and the mean value will be used for analysis. The activation ratio is dimensionless. Bilateral measurements will be used for side and group comparisons.
16 secondary outcomes
Standing Postural Sway
Time frame: Day 1
Percentage of Remaining Limb
Time frame: Day 1
Prosthesis Awareness
Time frame: Day 1
Fear of Falling
Time frame: Day 1
Reaction Time During Limits of Stability Test
Time frame: Day 1
Movement Velocity During Limits of Stability Test
Time frame: Day 1
Endpoint Excursion During Limits of Stability Test
Time frame: Day 1
Maximum Excursion During Limits of Stability Test
Time frame: Day 1
Directional Control During Limits of Stability Test
Time frame: Day 1
Weight Transfer Time During Sit-to-Stand
Time frame: Day 1
Rising Index During Sit-to-Stand
Time frame: Day 1
Postural Sway Velocity After Sit-to-Stand
Time frame: Day 1
Weight-Bearing Asymmetry During Sit-to-Stand
Time frame: day 1
Lift-Up Index During the Step Up/Over Task
Time frame: Day 1
Movement Time During the Step Up/Over Task
Time frame: day 1
Impact Index During the Step Up/Over Task
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 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.
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 Ultrasonography, 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 8 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: looking for participants now, as of the sponsor's last update on 15 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seher Özyürek, Prof. (0 232 4124935, seherozyurek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragm Thickening Fraction (time frame: Day 1). The study lists 3 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 Oct 2026.