AmputeeNCT06849934
Reliability of Kinovea Software for Measurement of Transtibial Amputee Knee Kinematics
An observational study of Amputee and Amputees, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 15 Aug 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who have unilateral transtibial amputation
Who may be able to join
- Having a unilateral below-knee (transtibial) level amputation,
- Using a prosthesis and being able to walk with the prosthesis,
- Body mass index less than 30,
- No contracture in the intact or amputated knee.
- Not having had any surgery related to the knees.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of Kinovea Software for Measurement of Transtibial Amputee Knee Angle During Walking
The primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. The secondary objective was to calculate the absolute reliability by calculating the Standard Error of Measurement (SEM), SEM% and Minimal Detectable Change at 95% confidence interval (MDC95). The SEM value represents the extent to which a score changes during the repetition of the measurement. The MDC is the minimum change in the measurement that is considered a true change in the measured activity that is not due to error.
- Keywords
- amputee, motion analysis, kinematics, reliability
What is being measured
The primary outcome is the main question the study is designed to answer.
Vİdeo Recording
The gait of the individuals will be recorded to determine the sagittal plane knee angular values during walking:
Participants will be asked to wear comfortable clothing to avoid limitation of movement. Before recording any measurements, participants will be asked to walk a few laps around the test area to familiarize them with the procedure and the movements being measured. Video images of each participant will be acquired using a digital camera (Canon EOS600D) to capture the sagittal plane profile of the knee. The camera will be placed on a tripod at a height of 80 cm, 1.5 m away from the participants. The tripod will be placed on taped markers on the floor to maintain the same distance between the camera and the participants. All images will be transferred to a laptop and analyzed using Kinovea software, a free, open source software created for motion analysis (Kinovea, 0.8.15, http://www.kinovea.org/).
Measured: From enrollment to the end of video record (10 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Dec 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeeStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay Çerezci Duygu, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849934
- Sponsor's protocol ID
- 2024-173
- Status last verified
- Sep 2024
- First submitted
- 23 Feb 2025
- Last updated
- 27 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of Kinovea Software for Measurement of Transtibial Amputee Knee Angle During Walking
- ClinicalTrials.gov ID
- NCT06849934
- Acronym / sponsor ID
- 2024-173
- Keywords
- amputee, motion analysis, kinematics, reliability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 27 Feb 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 primary aim of this study was to find the reliability of Kinovea software in measuring parameters associated with sagittal plane knee kinematics during gait in transtibial amputees. The secondary objective was to calculate the absolute reliability by calculating the Standard Error of Measurement (SEM), SEM% and Minimal Detectable Change at 95% confidence interval (MDC95). The SEM value represents the extent to which a score changes during the repetition of the measurement. The MDC is the minimum change in the measurement that is considered a true change in the measured activity that is not due to error.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who have unilateral transtibial amputation
Key inclusion criteria (5 listed)
- Having a unilateral below-knee (transtibial) level amputation,
- Using a prosthesis and being able to walk with the prosthesis,
- Body mass index less than 30,
- No contracture in the intact or amputated knee.
- Not having had any surgery related to the knees.
Key exclusion criteria (0 listed)
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
Vİdeo Recording
Time frame: From enrollment to the end of video record (10 minutes).
The gait of the individuals will be recorded to determine the sagittal plane knee angular values during walking: Participants will be asked to wear comfortable clothing to avoid limitation of movement. Before recording any measurements, participants will be asked to walk a few laps around the test area to familiarize them with the procedure and the movements being measured. Video images of each participant will be acquired using a digital camera (Canon EOS600D) to capture the sagittal plane profile of the knee. The camera will be placed on a tripod at a height of 80 cm, 1.5 m away from the participants. The tripod will be placed on taped markers on the floor to maintain the same distance between the camera and the participants. All images will be transferred to a laptop and analyzed using Kinovea software, a free, open source software created for motion analysis (Kinovea, 0.8.15, http://www.kinovea.org/).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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 Amputee and Amputees, run by Saglik Bilimleri Universitesi 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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 27 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?
Results are not available in the source record.
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?
Vİdeo Recording (time frame: From enrollment to the end of video record (10 minutes).). 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 27 Feb 2025.