Transfemoral AmputeesNCT06773559
Comparison of Transfemoral Amputees in Different Prosthesis Use Periods
An observational study of Transfemoral Amputees, run by Lokman Hekim University at 1 site in Turkey (Türkiye).
Trial summary
Nowadays, the use of prostheses is recognised as a critical rehabilitation tool for individuals who have experienced limb loss as a result of amputation in order to improve their quality of life and help them return to their activities of daily living. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Transfemoral Amputees
- What is being tested?
- plantar pressure, gait and static balance analysis and trunk posture analysis
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2024to 8 Nov 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: Volunteer transfemoral amputees and healthy adults
Who may be able to join
- To be using unilateral hydraulic knee joint and carbon foot prosthesis.
- Being amputee at the transfemoral level
- Being new or using prosthesis for at least 3 years.
- Having undergone amputation due to trauma.
- To have completed prosthetic period rehabilitation.
- To be between the ages of 18-45
Who cannot join
- Having a wound-ulcer problem
- Having amputation due to diabetes, peripheral arterial disease, tumour or venous insufficiency
- Being diagnosed with any systemic or neurological disease
- Affected perception and cognition
- Body mass index above 30.
- Having lower extremity contracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Lokman Hekim University
Ankara, Sogutozu, 06530
About this study
Official title: Comparison of Posture, Balance, Gait and Plantar Pressure Parameters of Transfemoral Amputees in Different Prosthesis Use Periods
Nowadays, the use of prostheses is recognised as a critical rehabilitation tool for individuals who have experienced limb loss as a result of amputation in order to improve their quality of life and help them return to their activities of daily living. Prostheses offer the potential to help these individuals regain their mobility as well as optimise their physical function. Especially for unilateral transfemoral amputees, there are a number of physical challenges they face during prosthesis use. These challenges can manifest as posture, balance and weight transfer problems that prosthesis users face in their daily lives. Correcting trunk posture, increasing the ability to maintain static balance and optimising plantar load distribution are critical factors affecting the success of prosthesis use. These challenges faced by unilateral transfemoral amputees during prosthesis use are closely related to post-amputation biomechanical changes. These changes can often lead to problems with balance, gait and functionality during activities of daily living. There is no effective comparative study based on computerised analysis data on posture assessment, static balance and plantar pressure distribution of transfemoral amputees.The aim of this study was to investigate the effects of prosthesis use by comparing posture, balance, gait and plantar pressure parameters of unilateral transfemoral amputees at different prosthesis use periods
- Conditions
- Transfemoral Amputees
- Being tested
- plantar pressure, gait and static balance analysis, trunk posture analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar pressure, gait and static balance analysisDiagnostic test
Plantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles.
trunk posture analysisDiagnostic test
Trunk posture analysis was performed using Diers Formetric 4D.
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral amputee group using prosthesis for at least 3 years | Not described Receives: Diagnostic Test: plantar pressure, gait and static balance analysis; Diagnostic Test: trunk posture analysis | |
| New transfemoral amputee group using prosthesis between two and six weeks | Not described Receives: Diagnostic Test: plantar pressure, gait and static balance analysis; Diagnostic Test: trunk posture analysis | |
| Healthy adult group | Not described Receives: Diagnostic Test: plantar pressure, gait and static balance analysis; Diagnostic Test: trunk posture analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar pressure analysis
It was evaluated using the insoles of the Ultium Insole SmartLead. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It is also capable of providing users with zoned and total normalised load-time curves. In addition, it provides users with data such as 3D pressure animations and pressure centre, enabling a more detailed analysis of load distribution. These features make load distribution analysis for clinical or research purposes more effective and user-friendly. It also provides the possibility to monitor relative load distribution during balancing and bilateral or unilateral exercise applications. Applications of this technology include static and dynamic load imbalance detection, and body sway analysis.
Measured: Baseline
Gait analysis
Duration-distance characteristics of gait were evaluated using Ultium Insole SmartLead insoles. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It enables contact detection and quantitative analysis in walking, running and other dynamic activities. Applications of this technology include gait analysis, and running analysis.
Measured: Baseline
Secondary outcomes (4)
Trunk posture analysis
Evaluated with the DIERS Formetric 4D Analysis System. The system offers the ability to perform fast and radiation-free static and dynamic (functional) optical measurements of the human spine. This system works without contact and can objectively analyse spinal posture, scoliosis and other spinal deformities with various clinical parameters.
Measured: Baseline
Fear of falling
It was assessed with the International Falls Efficacy Scale (FES-I): Fear of falling can reduce a person's quality of life and lead to a range of negative consequences, including psychological distress, increased medication use, activity limitations, decreased physical functioning, increased risk of falls, and the need for institutional care. The FES measures confidence in performing activities of daily living without falling. This scale has an excellent performance in terms of reliability and is correlated with balance and gait measures. It is also known for its ability to predict future falls and decline in functional capacity. The FES-I is a scale used to assess fear of falling and was developed as an international version of the Falls Efficacy Scale. The FES-I is used to assess individuals' fear of falling and their confidence in performing daily activities. The FES-I is frequently used by health professionals to determine fear of falling and to assess the need for intervention.
Measured: Baseline
Body image
It was evaluated with the Amputee Body Image Scale (ABIS). The scale is recognised as an important tool in the process of understanding and improving the body image of amputees. It was developed to assess the body experiences of amputees. The ABIS contains 20 items and measures the perceptions and feelings of the person about his/her body after amputation. During its development, important psychometric properties such as content validity, internal consistency and validity were found acceptable.
Measured: Baseline
Satisfaction level
It was evaluated with the Prosthesis Satisfaction Questionnaire. This questionnaire assesses the satisfaction of amputees with their prostheses. The questionnaire consists of 15 questions, and for each question, the participants tick one of the following options: 3: completely agree, 2: strongly agree, 1: disagree, 0: strongly disagree and receive the appropriate score. The total score ranges from 0 to 45, with higher scores indicating higher levels of satisfaction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start5 Apr 2024
- Primary completion18 Jul 2024
- Study completion8 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral AmputeesStudies 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
- 24 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Lokman Hekim University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mustafa Sarı, Lokman Hekim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773559
- Sponsor's protocol ID
- 2023187
- Status last verified
- Jan 2025
- First submitted
- 9 Nov 2024
- Last updated
- 14 Jan 2025
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Posture, Balance, Gait and Plantar Pressure Parameters of Transfemoral Amputees in Different Prosthesis Use Periods
- ClinicalTrials.gov ID
- NCT06773559
- Acronym / sponsor ID
- 2023187
- Conditions
- Transfemoral Amputees
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Lokman Hekim UniversityOther government
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 18 Jul 2024 (actual)
- Study completion
- 8 Nov 2024 (actual)
- First posted
- 14 Jan 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.
Nowadays, the use of prostheses is recognised as a critical rehabilitation tool for individuals who have experienced limb loss as a result of amputation in order to improve their quality of life and help them return to their activities of daily living. Prostheses offer the potential to help these individuals regain their mobility as well as optimise their physical function. Especially for unilateral transfemoral amputees, there are a number of physical challenges they face during prosthesis use. These challenges can manifest as posture, balance and weight transfer problems that prosthesis users face in their daily lives. Correcting trunk posture, increasing the ability to maintain static balance and optimising plantar load distribution are critical factors affecting the success of prosthesis use. These challenges faced by unilateral transfemoral amputees during prosthesis use are closely related to post-amputation biomechanical changes. These changes can often lead to problems with balance, gait and functionality during activities of daily living. There is no effective comparative study based on computerised analysis data on posture assessment, static balance and plantar pressure distribution of transfemoral amputees.The aim of this study was to investigate the effects of prosthesis use by comparing posture, balance, gait and plantar pressure parameters of unilateral transfemoral amputees at different prosthesis use periods
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transfemoral amputee group using prosthesis for at least 3 years | – | Diagnostic Test: plantar pressure, gait and static balance analysis, Diagnostic Test: trunk posture analysis |
| New transfemoral amputee group using prosthesis between two and six weeks | – | Diagnostic Test: plantar pressure, gait and static balance analysis, Diagnostic Test: trunk posture analysis |
| Healthy adult group | – | Diagnostic Test: plantar pressure, gait and static balance analysis, Diagnostic Test: trunk posture analysis |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Volunteer transfemoral amputees and healthy adults
Key inclusion criteria (6 listed)
- To be using unilateral hydraulic knee joint and carbon foot prosthesis.
- Being amputee at the transfemoral level
- Being new or using prosthesis for at least 3 years.
- Having undergone amputation due to trauma.
- To have completed prosthetic period rehabilitation.
Key exclusion criteria (6 listed)
- Having a wound-ulcer problem
- Having amputation due to diabetes, peripheral arterial disease, tumour or venous insufficiency
- Being diagnosed with any systemic or neurological disease
- Affected perception and cognition
- Body mass index above 30.
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 |
|---|---|---|
| plantar pressure, gait and static balance analysisPlantar pressure, gait and static balance analysis performed using Ultium Insole SmartLead insoles. | Diagnostic test | Healthy adult group, New transfemoral amputee group using prosthesis between two and six weeks, Transfemoral amputee group using prosthesis for at least 3 years |
| trunk posture analysisTrunk posture analysis was performed using Diers Formetric 4D. | Diagnostic test | Healthy adult group, New transfemoral amputee group using prosthesis between two and six weeks, Transfemoral amputee group using prosthesis for at least 3 years |
Primary outcome
Plantar pressure analysis
Time frame: Baseline
It was evaluated using the insoles of the Ultium Insole SmartLead. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It is also capable of providing users with zoned and total normalised load-time curves. In addition, it provides users with data such as 3D pressure animations and pressure centre, enabling a more detailed analysis of load distribution. These features make load distribution analysis for clinical or research purposes more effective and user-friendly. It also provides the possibility to monitor relative load distribution during balancing and bilateral or unilateral exercise applications. Applications of this technology include static and dynamic load imbalance detection, and body sway analysis.
Gait analysis
Time frame: Baseline
Duration-distance characteristics of gait were evaluated using Ultium Insole SmartLead insoles. This system is compatible with the Ultium EMG system and can be used in a portable laboratory environment. It enables contact detection and quantitative analysis in walking, running and other dynamic activities. Applications of this technology include gait analysis, and running analysis.
4 secondary outcomes
Trunk posture analysis
Time frame: Baseline
Fear of falling
Time frame: Baseline
Body image
Time frame: Baseline
Satisfaction level
Time frame: Baseline
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 14 Jan 2025.
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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 Transfemoral Amputees, run by Lokman Hekim 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 6 inclusion and 6 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 14 Jan 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?
Plantar pressure analysis (time frame: Baseline). The study lists 2 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 14 Jan 2025.