- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06928194
Reliability of Kinovea in Gait Assessment in Multiple Sclerosis: a Pilot Study. (KV-MS)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sevilla, Spain, 41015
- NeuroLab-Lázaro
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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Distance between the two heel strike points during initial contact of opposing feet.
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With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
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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.
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Distance between the two heel strike points during initial contact of the same foot.
Two step lengths add up to one stride length.
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With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
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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.
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Distance between the midpoints of the heels of two consecutive steps
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With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
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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.
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Number of steps taken during a given period
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With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
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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.
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Time taken to walk a known distance
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With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Carlos Luque Moreno, University of Seville
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SICEIA-2025-000557
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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