NCT06928194

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
Last Updated

April 18, 2025

Status Verified

April 1, 2025

Enrollment Period

23 days

First QC Date

April 7, 2025

Last Update Submit

April 15, 2025

Conditions

Keywords

Multiple SclerosisGait Disorders, NeurologicKinoveaGAITRite

Outcome Measures

Primary Outcomes (5)

  • Step length (cm)

    Distance between the two heel strike points during initial contact of opposing feet.

    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.

    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

    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

    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

    With the GAITRite system, measurement is instantaneous, while with the Kinovea system, measurement of all parameters took 2 hours for each patient.

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NeuroLab-Lázaro

Seville, Sevilla, 41015, Spain

Location

MeSH Terms

Conditions

Multiple SclerosisGait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos Luque Moreno

    University of Seville

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, student of a master's degree in Neurological Physiotherapy

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

March 10, 2025

Primary Completion

April 2, 2025

Study Completion

April 2, 2025

Last Updated

April 18, 2025

Record last verified: 2025-04

Locations