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.
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.
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.
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
Speed
Distance travelled in the unit of time, expressed in meters/seconds .Kinematic parameter to define reliability
Measured: One Week
Cadence
Number of steps performed on the unit of time. Kinematic parameter to define reliability
Measured: One Week
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
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
Hip Range of Motion
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Knee Range of Motion
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Ankle Range of Motion
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Minimum Hip angle
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Minimum Knee angle
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Minimum Ankle angle
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Maximum Hip angle
In Degrees. Kinematic parameter to define reliability
Measured: One Week
Maximum Knee angle
In Degrees. Kinematic parameter to define reliability
Measured: One Week
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.
- First posted13 Sep 2022
- Study start20 Oct 2022
- Primary completion4 Nov 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gait AnalysisStudies 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
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Integral de Neurologia y Especialidades Afines, Argentina
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Favaloro, Institut Guttmann
- Responsible party
- Principal investigator, Bernardo Centeno, Centro Integral de Neurologia y Especialidades Afines, Argentina
- Investigators
- Bernardo Centeno, Principal investigator, Centro Integral de Neurologia y Especialidades Afines, Argentina
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of a Low-cost Video-based Gait Analysis System
- ClinicalTrials.gov ID
- NCT05538221
- Acronym / sponsor ID
- ConfSilema
- Conditions
- Gait Analysis
- Keywords
- Gait, Reliability, Video, Kinematics, Temporo Spatial Parameters
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Centro Integral de Neurologia y Especialidades Afines, ArgentinaUniversity, hospital or other
- Collaborators
- Fundación Favaloro, Institut Guttmann
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 4 Nov 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 13 Sep 2022 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (1 listed)
- Age between 18 and 60 years
Key exclusion criteria (3 listed)
- History of any condition (neuromuscular, cardiovascular and/or musculoskeletal) that could generate an atypical gait pattern
- Pregnancy
- Known hypersensitivity to adhesive tape
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SILEMASILEMA 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. | Diagnostic test | – |
Primary outcome
Step Length
Time frame: One Week
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
Speed
Time frame: One Week
Distance travelled in the unit of time, expressed in meters/seconds .Kinematic parameter to define reliability
Cadence
Time frame: One Week
Number of steps performed on the unit of time. Kinematic parameter to define reliability
Stance Time
Time frame: One Week
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
Swing Time
Time frame: One Week
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
Hip Range of Motion
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Knee Range of Motion
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Ankle Range of Motion
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Minimum Hip angle
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Minimum Knee angle
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Minimum Ankle angle
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Maximum Hip angle
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Maximum Knee angle
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
Maximum Ankle angle
Time frame: One Week
In Degrees. Kinematic parameter to define reliability
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 8 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Smartphone Video-Based AI Gait Analysis Reports to Support Remote Follow-up After Total Knee Arthroplasty
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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.
Bernardo Centeno principal investigator
Centro Integral de Neurologia y Especialidades Afines, Argentina
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 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.