Transfemoral AmputationNCT07032233
Assessment of Strength, Balance, and Function in Above-Knee Amputees in Relation to Residual Limb Length
An observational study of Transfemoral Amputation, run by Ceren Kuzu at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations. The main questions it aims to answer are: How does the length of the lost part of the leg, compared to the intact leg, affect muscle strength… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Transfemoral Amputation
- How many people
- 15 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2025to Nov 2026
- How long will I take part?
- 5 Days
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants will be selected from the population of adults with unilateral transfemoral amputation who are able to ambulate independently with a prosthesis. The target population includes individuals between the ages of 18 and 50 who have been using a prosthesis for at least 6 months. Eligible participants must be literate and free from cardiovascular, orthopedic, cognitive, or neurological conditions that could interfere with gait, balance, or muscle strength. Recruitment may occur through rehabilitation clinics, prosthetics centers, or community referrals.
Who may be able to join
- Individuals will be included in the study if they:
- Are between 18 and 50 years of age
- Are literate
- Have unilateral transfemoral amputation
- Have no cardiovascular, orthopedic, cognitive, or neurological conditions that could negatively affect balance, gait, or muscle strength
- Are able to ambulate independently with a prosthesis
- Have been walking for at least 6 months
- Voluntarily agree to participate in the study
Who cannot join
- Participants will be excluded from the study if:
- They develop complications such as pain (rated 3 or higher on the Visual Analog Scale) or stump irritation during the course of the study
- Their residual limb length is less than 25 cm from the greater trochanter, which exceeds the limitations of the isokinetic dynamometer attachments used in the study
- They voluntarily withdraw from the study - in such cases, their data will be removed from the records
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
Gaziler Physical Therapy and Rehabilitation Training and Research Hospital
Ankara, Ankara, 06800
Ceren Kuzu, Msc. PT, 90+312-291-1000, ce.kuzu@gmail.com
About this study
Official title: Assessment of Lower Extremity Muscle Strength, Balance, and Functional Capacity in Individuals With Transfemoral Amputation and Investigation of the Relationship With the Length of the Lost Extremity
The goal of this observational study is to learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations. The main questions it aims to answer are:
How does the length of the lost part of the leg, compared to the intact leg, affect muscle strength, balance, and functional capacity?
Read more
Is muscle strength at specific lower limb joints related to balance and performance ?
Participants will:
Have muscle strength measured at all intact lower limb joints using an isokinetic dynamometer
Complete balance assessments using force platform technology that measures weight distribution and evaluates both static and dynamic balance
Perform a six-minute walk test to evaluate endurance and functional capacity
The study will help improve understanding of how limb length and joint-specific muscle strength impact mobility, supporting the development of better rehabilitation programs for amputees.
Read the detailed description
This study is a cross-sectional observational study designed to assess lower extremity muscle strength, balance, and functional capacity in individuals with unilateral transfemoral amputation. The primary aim is to examine how the length of the lost part of the limb, in relation to the intact limb, correlates with these physical performance parameters. This study does not involve any intervention or follow-up over time. All data will be collected at one time point. Therefore, although the registry requires a study model selection, the study design does not align with standard cohort or case-control models. For this reason, the "Other" option was selected as the most appropriate observational study model.
- Conditions
- Transfemoral Amputation
- Keywords
- Transfemoral Amputation, Muscle Strength, Isokinetic Dynamometry, Balance Assessment, Functional Capacity, Residual Limb Length, Prosthetics, Postural Control, Gait, Six-Minute Walk Test, Mobility
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 |
|---|---|---|
| transfemoral amputation | Adults with unilateral transfemoral amputation who indepently ambulates with a prosthetic limb. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%)
Anthropometric measurements will be performed using a standard measuring tape. For the amputated limb, the distance will be measured from the greater trochanter to the distal end of the residual limb along the lateral midline. For the intact limb, the measurement will extend from the greater trochanter to the plantar surface of the foot. The difference between these two measurements will represent the length of the lost limb. The percentage of limb loss will then be calculated by comparing the lost length to the total length of the intact limb.
Measured: 1 day
Isokinetic Strength Testing
Isokinetic muscle strength assessments will be conducted using the IsoMed 2000 Dynamometer (D\&R Ferstl GmbH, Hemau, Germany). Measurements will include peak torque (Nm) and total work (J) values for hip, knee, and ankle flexor/extensor muscles. Testing will be performed under the following angular velocities and repetitions:
- Hip Flexion/Extension: 5 reps at 60°/s, 10 reps at 120°/s (supine position)
- Knee Flexion/Extension: 5 reps at 60°/s, 10 reps at 180°/s (seated, hip at 90°)
- Ankle Plantar/Dorsiflexion: 5 reps at 60°/s, 10 reps at 120°/s (seated, semi-flexed hip, 90° knee flexion) Rest periods will be given between measurements to minimize fatigue. Tests will be randomized across different joints and days to avoid order effects.
Data will be summarized as peak torque and total work values for each muscle group at the specified angular velocities.
Measured: 5 days
Stability Coefficient (Eyes Open and Closed), Single-Leg Stability of Intact Side, and Limits of Stability (mm)
Participants' balance abilities will be assessed using the Huber 360® Evolution (LPG Systems, Valence, France), a motorized multi-axial platform with integrated force sensors. The following parameters will be measured and reported:
- Static balance with eyes open and eyes closed (coefficient of stability)
- Single-Leg Stability on the intact limb (coefficient of stability)
- Limits of stability quantified as sway in mm
Measured: 1 day
6 minute walk test
Measured: 1 day
Timed Up and Go (TUG)
The Timed Up and Go test is a functional mobility test used to assess mobility and balance. The participant is instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the test is measured in seconds. The test is performed three times, and the mean of the three trials is recorded as the final score. Lower completion times indicate better functional mobility.
Measured: 5 minutes
Secondary outcomes (2)
The Amputee Mobility Predictor (AMP)
Mobility level will be assessed using the Amputee Mobility Predictor (AMP) scale. This performance-based tool includes 21 items covering balance while sitting, transfers, standing balance, walking, stair climbing, and assistive device use. Scores range from 0 to 47, with higher scores indicating better mobility. Based on the scores, participants will be classified according to the Medicare Functional Classification Levels (K-levels), which are defined by the United States Centers for Medicare \& Medicaid Services (CMS) to standardize functional mobility and prosthetic eligibility.
Measured: 1 day
The Comprehensive Lower-limb Amputee Socket Survey (CLASS)
Socket fit and comfort will be evaluated using The Comprehensive Lower-limb Amputee Socket Survey (CLASS), a validated self-report questionnaire developed by Gailey et al. The survey includes 15 items assessing four domains: stability, suspension, comfort, and appearance of the prosthetic socket. Each item is rated on a 4-point ordinal scale, and total scores are converted into a percentage score ranging from 0% to 100%, with higher percentages indicating better socket fit and greater user satisfaction.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start26 Jun 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (estimated)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Ceren Kuzu
- Sponsor type
- University, hospital or other
- Collaborators
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, Hacettepe University
- Responsible party
- Sponsor-investigator, Ceren Kuzu, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032233
- Sponsor's protocol ID
- FTREK25/31
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, it is undecided whether individual participant data (IPD) will be shared. This study is part of an early-stage academic research project, and decisions regarding data sharing will depend on institutional policies, data protection considerations, and future collaboration opportunities. If a data-sharing plan is established, the study record will be updated accordingly.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Lower Extremity Muscle Strength, Balance, and Functional Capacity in Individuals With Transfemoral Amputation and Investigation of the Relationship With the Length of the Lost Extremity
- ClinicalTrials.gov ID
- NCT07032233
- Acronym / sponsor ID
- FTREK25/31
- Conditions
- Transfemoral Amputation
- Keywords
- Transfemoral Amputation, Muscle Strength, Isokinetic Dynamometry, Balance Assessment, Functional Capacity, Residual Limb Length, Prosthetics, Postural Control
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ceren KuzuUniversity, hospital or other
- Collaborators
- Gaziler Physical Medicine and Rehabilitation Education and Research Hospital, Hacettepe University
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 22 Jun 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 learn how muscle strength, balance, and functional ability are affected in people with above-knee (transfemoral) amputations. The main questions it aims to answer are:
How does the length of the lost part of the leg, compared to the intact leg, affect muscle strength, balance, and functional capacity?
Is muscle strength at specific lower limb joints related to balance and performance ?
Participants will:
Have muscle strength measured at all intact lower limb joints using an isokinetic dynamometer
Complete balance assessments using force platform technology that measures weight distribution and evaluates both static and dynamic balance
Perform a six-minute walk test to evaluate endurance and functional capacity
The study will help improve understanding of how limb length and joint-specific muscle strength impact mobility, supporting the development of better rehabilitation programs for amputees.
Detailed description
This study is a cross-sectional observational study designed to assess lower extremity muscle strength, balance, and functional capacity in individuals with unilateral transfemoral amputation. The primary aim is to examine how the length of the lost part of the limb, in relation to the intact limb, correlates with these physical performance parameters. This study does not involve any intervention or follow-up over time. All data will be collected at one time point. Therefore, although the registry requires a study model selection, the study design does not align with standard cohort or case-control models. For this reason, the "Other" option was selected as the most appropriate observational study model.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| transfemoral amputation | – | –Adults with unilateral transfemoral amputation who indepently ambulates with a prosthetic limb. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants will be selected from the population of adults with unilateral transfemoral amputation who are able to ambulate independently with a prosthesis. The target population includes individuals between the ages of 18 and 50 who have been using a prosthesis for at least 6 months. Eligible participants must be literate and free from cardiovascular, orthopedic, cognitive, or neurological conditions that could interfere with gait, balance, or muscle strength. Recruitment may occur through rehabilitation clinics, prosthetics centers, or community referrals.
Key inclusion criteria (8 listed)
- Are between 18 and 50 years of age
- Are literate
- Have unilateral transfemoral amputation
- Have no cardiovascular, orthopedic, cognitive, or neurological conditions that could negatively affect balance, gait, or muscle strength
- Are able to ambulate independently with a prosthesis
Key exclusion criteria (4 listed)
- They develop complications such as pain (rated 3 or higher on the Visual Analog Scale) or stump irritation during the course of the study
- Their residual limb length is less than 25 cm from the greater trochanter, which exceeds the limitations of the isokinetic dynamometer attachments used in the study
- They voluntarily withdraw from the study - in such cases, their data will be removed from the records
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
Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%)
Time frame: 1 day
Anthropometric measurements will be performed using a standard measuring tape. For the amputated limb, the distance will be measured from the greater trochanter to the distal end of the residual limb along the lateral midline. For the intact limb, the measurement will extend from the greater trochanter to the plantar surface of the foot. The difference between these two measurements will represent the length of the lost limb. The percentage of limb loss will then be calculated by comparing the lost length to the total length of the intact limb.
Isokinetic Strength Testing
Time frame: 5 days
Isokinetic muscle strength assessments will be conducted using the IsoMed 2000 Dynamometer (D\&R Ferstl GmbH, Hemau, Germany). Measurements will include peak torque (Nm) and total work (J) values for hip, knee, and ankle flexor/extensor muscles. Testing will be performed under the following angular velocities and repetitions: 1. Hip Flexion/Extension: 5 reps at 60°/s, 10 reps at 120°/s (supine position) 2. Knee Flexion/Extension: 5 reps at 60°/s, 10 reps at 180°/s (seated, hip at 90°) 3. Ankle Plantar/Dorsiflexion: 5 reps at 60°/s, 10 reps at 120°/s (seated, semi-flexed hip, 90° knee flexion) Rest periods will be given between measurements to minimize fatigue. Tests will be randomized across different joints and days to avoid order effects. Data will be summarized as peak torque and total work values for each muscle group at the specified angular velocities.
Stability Coefficient (Eyes Open and Closed), Single-Leg Stability of Intact Side, and Limits of Stability (mm)
Time frame: 1 day
Participants' balance abilities will be assessed using the Huber 360® Evolution (LPG Systems, Valence, France), a motorized multi-axial platform with integrated force sensors. The following parameters will be measured and reported: 1. Static balance with eyes open and eyes closed (coefficient of stability) 2. Single-Leg Stability on the intact limb (coefficient of stability) 3. Limits of stability quantified as sway in mm
6 minute walk test
Time frame: 1 day
Timed Up and Go (TUG)
Time frame: 5 minutes
The Timed Up and Go test is a functional mobility test used to assess mobility and balance. The participant is instructed to stand up from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. The time required to complete the test is measured in seconds. The test is performed three times, and the mean of the three trials is recorded as the final score. Lower completion times indicate better functional mobility.
2 secondary outcomes
The Amputee Mobility Predictor (AMP)
Time frame: 1 day
The Comprehensive Lower-limb Amputee Socket Survey (CLASS)
Time frame: 1 day
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 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. At this stage, it is undecided whether individual participant data (IPD) will be shared. This study is part of an early-stage academic research project, and decisions regarding data sharing will depend on institutional policies, data protection considerations, and future collaboration opportunities. If a data-sharing plan is established, the study record will be updated accordingly.
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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 Transfemoral Amputation, run by Ceren Kuzu 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 4 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 16 Sep 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 Ceren Kuzu, MSc, Physical Therapist (+905067027093, ce.kuzu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Residual Limb and Intact Limb (cm) and Percentage of Limb Loss (%) (time frame: 1 day). The study lists 5 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 16 Sep 2026.