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Gait AnalysisNCT05538221

Reliability of a Gait Analysis System

An observational study of Gait Analysis, run by Centro Integral de Neurologia y Especialidades Afines, Argentina at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gait Analysis
What is being tested?
SILEMA
How many people
18 participants
Where
1 siteArgentina
Study dates
20 Oct 2022to 4 Nov 2022
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy adult volunteers

Who may be able to join

  • Age between 18 and 60 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Argentina1 site
  • CINEA

    San Miguel de Tucumán, Tucumám, 4000

Other trials in Argentina

About this study

Official title: Reliability of a Low-cost Video-based Gait Analysis System

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.

Conditions
Gait Analysis
Being tested
SILEMA
Keywords
Gait, Reliability, Video, Kinematics, Temporo Spatial Parameters

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SILEMADiagnostic test

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: One Week

  2. Speed

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

    Measured: One Week

  3. Cadence

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

    Measured: 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

    Measured: 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

    Measured: One Week

  6. Hip Range of Motion

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  7. Knee Range of Motion

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  8. Ankle Range of Motion

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  9. Minimum Hip angle

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  10. Minimum Knee angle

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  11. Minimum Ankle angle

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  12. Maximum Hip angle

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  13. Maximum Knee angle

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

  14. Maximum Ankle angle

    In Degrees. Kinematic parameter to define reliability

    Measured: One Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2022
  2. Study start20 Oct 2022
  3. Primary completion4 Nov 2022
  4. Study completion4 Nov 2022

Resources

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
Cross-sectional
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05538221
Sponsor's protocol ID
ConfSilema
Status last verified
Nov 2022
First submitted
9 Sep 2022
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Gait Analysis, run by Centro Integral de Neurologia y Especialidades Afines, Argentina at 1 site in Argentina.

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 1 inclusion and 3 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 8 Nov 2022. 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 Argentina. 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 (time frame: One Week). The study lists 14 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 8 Nov 2022.

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Reliability of a Gait Analysis System (NCT05538221) | AzTrials