Multiple SclerosisKV-MSNCT06928194
Reliability of Kinovea in Gait Assessment in Multiple Sclerosis: a Pilot Study.
An observational study of Multiple Sclerosis and Gait Disorders, Neurologic, run by University of Cadiz at 1 site in Spain.
Trial summary
The objective of this observational study is to determine whether the Kinovea video analysis tool is valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis, comparing the data obtained from this system with those of the gold standard, the GaitRite system. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Gait Disorders, Neurologic
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- 10 Mar 2025to 2 Apr 2025
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young-to-middle-aged people with multiple sclerosis who maintain the ability to walk and who come to the laboratory for their scheduled checkups.
Who may be able to join
- Patients scheduled for evaluation by the NeuroLab-Lázaro gait laboratory (Seville).
- Patients who have signed informed consent prior to the test.
- Patients between 18 and 55 years of age, diagnosed with MS according to the 2017 McDonald criteria.
- Patients with an EDSS score of less than 6.5 points.
- Patients who are willing to participate in the study and who do not object to being recorded while performing the gait test and to the use of images for educational and research purposes.
Who cannot join
- Patients who use walking aids and/or orthoses.
- Patients with comorbidity or decompensated systemic disease within the last month.
- Patients who have any physical impediment (excessive fatigue) to performing the gait test, as documented in their medical records reviewed on the Diraya platform.
- Patients who have suffered a relapse within 30 days prior to the start of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reliability of the Kinovea System in the Study of Spatiotemporal Gait Parameters in Multiple Sclerosis: a Pilot Study.
The objective of this observational study is to determine whether the Kinovea video analysis tool is valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis, comparing the data obtained from this system with those of the gold standard, the GaitRite system. The main question to be answered is:
Is the Kinovea system valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis?
Participants walked across the GAITRite platform four times without shoes and four times with shoes, while being recorded by two cameras simultaneously: one recorded gait from the sagittal plane and the other from the frontal plane.
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Keywords
- Multiple Sclerosis, Gait Disorders, Neurologic, Kinovea, GAITRite
- Medical subject headings
- Multiple Sclerosis, Gait Disorders, Neurologic
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length (cm)
Distance between the two heel strike points during initial contact of opposing feet.
Measured: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Stride length (cm)
Distance between the two heel strike points during initial contact of the same foot. Two step lengths add up to one stride length.
Measured: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Support base (cm)
Distance between the midpoints of the heels of two consecutive steps
Measured: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Cadence (steps/min)
Number of steps taken during a given period
Measured: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Walking speed (cm/s)
Time taken to walk a known distance
Measured: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Mar 2025
- Primary completion2 Apr 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Responsible party
- Principal investigator, Antonio Gil Centeno, University of Cadiz
- Investigators
- Carlos Luque Moreno, Study director, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06928194
- Sponsor's protocol ID
- SICEIA-2025-000557
- Acronym
- KV-MS
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 18 Apr 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of the Kinovea System in the Study of Spatiotemporal Gait Parameters in Multiple Sclerosis: a Pilot Study.
- ClinicalTrials.gov ID
- NCT06928194
- Acronym / sponsor ID
- KV-MS / SICEIA-2025-000557
- Conditions
- Multiple Sclerosis, Gait Disorders, Neurologic
- Keywords
- Multiple Sclerosis, Gait Disorders, Neurologic, Kinovea, GAITRite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Hospital Universitario Virgen Macarena
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 15 Apr 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 objective of this observational study is to determine whether the Kinovea video analysis tool is valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis, comparing the data obtained from this system with those of the gold standard, the GaitRite system. The main question to be answered is:
Is the Kinovea system valid and reliable for analyzing spatiotemporal gait parameters in multiple sclerosis?
Participants walked across the GAITRite platform four times without shoes and four times with shoes, while being recorded by two cameras simultaneously: one recorded gait from the sagittal plane and the other from the frontal plane.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young-to-middle-aged people with multiple sclerosis who maintain the ability to walk and who come to the laboratory for their scheduled checkups.
Key inclusion criteria (5 listed)
- Patients scheduled for evaluation by the NeuroLab-Lázaro gait laboratory (Seville).
- Patients who have signed informed consent prior to the test.
- Patients between 18 and 55 years of age, diagnosed with MS according to the 2017 McDonald criteria.
- Patients with an EDSS score of less than 6.5 points.
- Patients who are willing to participate in the study and who do not object to being recorded while performing the gait test and to the use of images for educational and research purposes.
Key exclusion criteria (4 listed)
- Patients who use walking aids and/or orthoses.
- Patients with comorbidity or decompensated systemic disease within the last month.
- Patients who have any physical impediment (excessive fatigue) to performing the gait test, as documented in their medical records reviewed on the Diraya platform.
- Patients who have suffered a relapse within 30 days prior to the start of the study.
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
Step length (cm)
Time frame: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Distance between the two heel strike points during initial contact of opposing feet.
Stride length (cm)
Time frame: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Distance between the two heel strike points during initial contact of the same foot. Two step lengths add up to one stride length.
Support base (cm)
Time frame: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Distance between the midpoints of the heels of two consecutive steps
Cadence (steps/min)
Time frame: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Number of steps taken during a given period
Walking speed (cm/s)
Time frame: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
Time taken to walk a known distance
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 18 Apr 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.
Carlos Luque Moreno study director
University of Seville
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 Multiple Sclerosis and Gait Disorders, Neurologic, run by University of Cadiz at 1 site in Spain.
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 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: finished, as of the sponsor's last update on 18 Apr 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 Spain. 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?
Step length (cm) (time frame: With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.). 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 18 Apr 2025.