AmputationNCT06586762
Sagittal Knee Kinematics of Transtibial Amputee with Running Blade
An observational study of Amputation and Prosthesis User, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Amputation, Prosthesis User
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2024to 30 Oct 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
- No healthy volunteers
- Adult
Study population: Unilateral transtibial amputee at K4 functional level
Who may be able to join
- body mass index below 30 kg/m2,
- Having unilateral transtibial amputation,
- Being at K4 functional level,
- Having an existing running blade,
- Being able to use RSP integrating it into their DUP,
- Having no self-reported problems with the residual limb or prosthesis, pain or skin lesions,
- Being active recreational runners (at least once a week) for at least 1 and up to 3 months without injury.
Who cannot join
- Having a history of knee surgery or contracture in the intact/amputee knee.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Ankara, Etlik Keçiören, 06010
About this study
Official title: Symmetry in Sagittal Knee Kinematics of Transtibial Amputee: Daily-Use Prosthesis Vs Running-Specific Prosthesis
Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms. Therefore, this study aims to evaluate the sagittal kinematics of the intact and residual knee in the use of Running-Specific Prostheses (RSP), which are increasing in popularity and use among amputees.
Materials and Methods: Participants will be video recorded in the sagittal plane to convert knee flexion motion into angles for the amputee and intact knee and to make measurements using the software's virtual goniometer. Recordings will be taken under the following two conditions: 1) walking at a self-selected walking speed with a Daily Use Prosthesis (DUP); 2) Slow running with RSP. The peak flexion during the swing phase and the initial flexion during the first contact of the stance phase will be recorded as angles in both conditions.
- Conditions
- Amputation, Prosthesis User
- Keywords
- amputee, symmetry, knee, running, running-specific prosthesis
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 |
|---|---|---|
| Daily-Use Prosthesis (DUP) | Participants are going video recorded in the sagittal plane, to convert knee flexion motion into angles for the amputated and intact knee and to make measurements using the software's virtual goniometer. The recording will be taken during walking at self-selected walking speed with DUP. | |
| Running-Specific Prosthesis (RSP) | Participants are going video recorded in the sagittal plane, to convert knee flexion motion into angles for the amputated and intact knee and to make measurements using the software's virtual goniometer. The recording will be taken during slow-running (heel-strike jogging) with RSP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)
In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during walking at self-selected walking speed with Daily-Use Prosthesis (DUP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.
Measured: Baseline
Sagital Knee Kinematics of intact and residual knee with Running-Specific Prosthesis (RSP)
In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during slow-running (jogging) with Running-Specific Prosthesis (RSP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.
Measured: Same day as baseline; 10 minutes after RSP integrated to prosthesis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Sep 2024
- Primary completion5 Oct 2024
- Study completion30 Oct 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
- 14 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Gulhane School of Medicine
- Responsible party
- Principal investigator, Senay Cerezci Duygu, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586762
- Sponsor's protocol ID
- 2024/369
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symmetry in Sagittal Knee Kinematics of Transtibial Amputee: Daily-Use Prosthesis Vs Running-Specific Prosthesis
- ClinicalTrials.gov ID
- NCT06586762
- Acronym / sponsor ID
- 2024/369
- Conditions
- Amputation, Prosthesis User
- Keywords
- amputee, symmetry, knee, running, running-specific prosthesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Gulhane School of Medicine
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Introduction: People with transtibial amputation often suffer musculoskeletal deformities in the form of knee osteoarthritis or osteophytosis due to asymmetric movement patterns and often complain of associated symptoms. Therefore, this study aims to evaluate the sagittal kinematics of the intact and residual knee in the use of Running-Specific Prostheses (RSP), which are increasing in popularity and use among amputees.
Materials and Methods: Participants will be video recorded in the sagittal plane to convert knee flexion motion into angles for the amputee and intact knee and to make measurements using the software's virtual goniometer. Recordings will be taken under the following two conditions: 1) walking at a self-selected walking speed with a Daily Use Prosthesis (DUP); 2) Slow running with RSP. The peak flexion during the swing phase and the initial flexion during the first contact of the stance phase will be recorded as angles in both conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily-Use Prosthesis (DUP) | – | –Participants are going video recorded in the sagittal plane, to convert knee flexion motion into angles for the amputated and intact knee and to make measurements using the software's virtual goniometer. The recording will be taken during walking at self-selected walking speed with DUP. |
| Running-Specific Prosthesis (RSP) | – | –Participants are going video recorded in the sagittal plane, to convert knee flexion motion into angles for the amputated and intact knee and to make measurements using the software's virtual goniometer. The recording will be taken during slow-running (heel-strike jogging) with RSP. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Unilateral transtibial amputee at K4 functional level
Key inclusion criteria (7 listed)
- body mass index below 30 kg/m2,
- Having unilateral transtibial amputation,
- Being at K4 functional level,
- Having an existing running blade,
- Being able to use RSP integrating it into their DUP,
Key exclusion criteria (1 listed)
- Having a history of knee surgery or contracture in the intact/amputee knee.
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
Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP)
Time frame: Baseline
In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during walking at self-selected walking speed with Daily-Use Prosthesis (DUP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.
Sagital Knee Kinematics of intact and residual knee with Running-Specific Prosthesis (RSP)
Time frame: Same day as baseline; 10 minutes after RSP integrated to prosthesis.
In the sagittal plan, knee flexion motion for the amputated and intact knee will be recorded during slow-running (jogging) with Running-Specific Prosthesis (RSP). The peak flexion during swing phase and the initial flexion during initial contact of the stance phase were recorded as angle.
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 25 Feb 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 Amputation and Prosthesis User, run by Baskent 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 7 inclusion and 1 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 25 Feb 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?
Sagital Knee Kinematics of intact and residual knee with Daily-Use Prosthesis (DUP) (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 25 Feb 2025.