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CompletedNCT05538221Updated Nov 8, 2022

Reliability of a Gait Analysis System

An observational study in Gait Analysis, sponsored by Centro Integral de Neurologia y Especialidades Afines, Argentina. Completed at 1 site in Argentina. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Centro Integral de Neurologia y Especialidades Afines, Argentina · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
18
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Gait disturbances can be observed in all age groups, and may be due to different conditions, such as advanced age, stroke, head trauma, spinal cord injury, cerebral palsy, myelomeningocele, among others. The aforementioned gait disorders are associated with an increased risk of falls (which can cause major fractures or head trauma), decreased mobility, loss of independence, cardiovascular pathology, and decreased quality of life. In order to improve a given abnormal gait pattern, an objective assessment of gait is necessary. There are several methods to carry out gait evaluations, like Instrumented Gait Analysis (High cost, time-consuming, qualified professionals needed) and the ones based on observation (limited reliability and validity). An alternative, is the use of video-based systems. SILEMA (Computer System for Gait Study Laboratories in Argentina) is a video-based low-cost gait analysis system that measures temporo-spatial (speed, step length, cadence, stance and swing times) and joint kinematic (Hip, Knee, Ankle) parameters. Its reliability has not been reported yet; thus the primary aim of this study is to determine both the "intra-evaluator" (same evaluator, different sessions) and "inter-evaluator" (same session, different evaluators) reliability.

Read the detailed description

Gait disturbances can be observed in all age groups, and may be due to different conditions, such as advanced age, stroke, head trauma, spinal cord injury, cerebral palsy, myelomeningocele, among others. The aforementioned gait disorders are associated with an increased risk of falls (which can cause major fractures or head trauma), decreased mobility, loss of independence, cardiovascular pathology, and decreased quality of life.

One of the main objectives of rehabilitation is the improvement of the gait pattern, for which a correct evaluation of it is a necessary condition. Gait analysis is the systematic study of human locomotion, with joint kinematics (description of movement in different planes) and temporo-spatial parameters (speed, cadence, step length, stance and swing times) being variables usually valued and reported. There are several methods for conducting gait assessments. One of them consists of the administration of scales based on observation, which are accessible and simple to execute, but exhibit limited reliability and validity, depending in addition to the previous experience of the observer. The method considered "Gold standard" is the Instrumented Gait Analysis (IGA), from which parameters of kinematics (through optoelectronic cameras and reflective markers), kinetics (through the use of force platforms) and muscle activity (using electromyography) can be obtained.Unfortunately, these systems are not available in most rehabilitation centers, due to the high cost they represent, the need to have highly trained professionals for their use and the long time needed for calibration and post-processing, difficulties that are continuously mentioned in the literature. An alternative to IGA is the use of video-based systems that allow the quantification of temporo-spatial parameters and joint kinematics. One of these systems is SILEMA(Computer System for Gait Study Laboratories in Argentina) which is based on the technique of digital videography. This system exhibits the advantages of being portable, easy to implement and use, and low cost.The purpose of the clinical analysis of gait is usually to differentiate between normal and abnormal patterns, and to assess the change over time or due to an intervention (surgery, orthosis, botulinum toxin, physical therapy, etc.), being necessary in the latter case to make repeated measurements. Usually, to carry out gait evaluations, the patient is asked to perform several "passes", each of them consisting of a free gait through a walkway, at a "self-selected" speed, during a session in which the corresponding information is collected. In healthy subjects, there is usually a variability between repeated measurements (both intra-subject and inter-subject), which occurs at the expense of intrinsic factors (age, height, gait speed, etc.) or extrinsic, caused by methodological errors (experimental error), such as those related to the placement of markers (task carried out by an evaluator, usually a Therapist, or with the processing of a video made by the operator of the software. The consistency or repeatability of the measurements is what is known as reliability. In other words, reliability is a measure of the variability that exists between repeated measurements, and is usually estimated, as recommended, using the intraclass correlation coefficient "ICC" (Relative Reliability) and the standard error of the measure "SEM" (Absolute Reliability). Its determination is very important, since in daily practice it could give information on whether the observed change in a certain parameter of the gait is due to the intervention / evolution of the pathology or to the variability of the measurements. In the context of gait analysis, reliability is typically evaluated "inter-pass" (between several passes of the same subject, in the same session), "intra-operator" (same video evaluated by the same operator at two different times), "interoperator" (same video, different operators), "intra-evaluator" (same evaluator, different sessions) and "inter-evaluator" (same session, different evaluators). To the best of our knowledge, the reliability of SILEMA has not been reported, being the objective of the present study, to determine this metric, with the intention of expanding its use, both for the clinic and for research.

02

Conditions studied

  • Gait Analysis

Keywords

  • Gait
  • Reliability
  • Video
  • Kinematics
  • Temporo Spatial Parameters
03

In context

Lead sponsor

This is the only study on the registry with Centro Integral de Neurologia y Especialidades Afines, Argentina as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Healthy adult volunteers

Inclusion criteria

  • Age between 18 and 60 years

Exclusion criteria

Exclusion Criteria:

  • History of any condition (neuromuscular, cardiovascular and/or musculoskeletal) that could generate an atypical gait pattern
  • Pregnancy
  • Known hypersensitivity to adhesive tape
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
18 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testSILEMA

    SILEMA consists of a webcam connected to a laptop, a LED reflector, and a software. To carry out gait analysis with SILEMA, an Evaluator must place six yellow auto-adhesive markers over certain anatomical landmarks in the lower limbs, namely, greater trochanter, external femoral condyle, head of the fibula, lateral malleolus and base and head of the fifth metatarsal. The patient is asked to walk barefoot through an eight meter walkway at a self-selected speed, while a webcam connected to a laptop records a video. Then, an Operator, making use of the software, processes the video, obtaining spatio-temporal and joint kinematic parameters.

06

What researchers measure

Primary outcomes

  1. Step Length

    Distance between the initial contact of one foot, and the next initial contact of the other foot, expressed in meters. Kinematic parameter to define reliability

    Time frame: One Week

  2. Speed

    Distance travelled in the unit of time, expressed in meters/seconds .Kinematic parameter to define reliability

    Time frame: One Week

  3. Cadence

    Number of steps performed on the unit of time. Kinematic parameter to define reliability

    Time frame: One Week

  4. Stance Time

    Time elapsed between the initial contact of one foot and the take-off of the toes of the same foot, expressed in seconds.Kinematic parameter to define reliability

    Time frame: One Week

  5. Swing Time

    Time elapsed between take-off of the toes and the next initial contact of the same foot, expressed in seconds. Kinematic parameter to define reliability

    Time frame: One Week

  6. Hip Range of Motion

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  7. Knee Range of Motion

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  8. Ankle Range of Motion

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  9. Minimum Hip angle

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  10. Minimum Knee angle

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  11. Minimum Ankle angle

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  12. Maximum Hip angle

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  13. Maximum Knee angle

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

  14. Maximum Ankle angle

    In Degrees. Kinematic parameter to define reliability

    Time frame: One Week

07

Study locations

1 site
  • CINEA
    San Miguel De Tucumán, Tucumám 4000, Argentina
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05538221
Lead sponsor
Centro Integral de Neurologia y Especialidades Afines, Argentina
Collaborators
Fundación Favaloro, Institut Guttmann
Responsible party
Bernardo Centeno (Medical Doctor, Centro Integral de Neurologia y Especialidades Afines, Argentina) — Principal investigator
First posted
Sep 13, 2022
Start date
Oct 20, 2022
Primary completion
Nov 4, 2022
Completion
Nov 4, 2022
Last update
Nov 8, 2022

Study contacts

Bernardo Centeno
principal investigator · Centro Integral de Neurologia y Especialidades Afines, Argentina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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