NCT05538221

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2022

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2022

Completed
Last Updated

November 8, 2022

Status Verified

November 1, 2022

Enrollment Period

15 days

First QC Date

September 9, 2022

Last Update Submit

November 4, 2022

Conditions

Keywords

GaitReliabilityVideoKinematicsTemporo Spatial Parameters

Outcome Measures

Primary Outcomes (14)

  • 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

    One Week

  • Speed

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

    One Week

  • Cadence

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

    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

    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

    One Week

  • Hip Range of Motion

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Knee Range of Motion

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Ankle Range of Motion

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Minimum Hip angle

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Minimum Knee angle

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Minimum Ankle angle

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Maximum Hip angle

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Maximum Knee angle

    In Degrees. Kinematic parameter to define reliability

    One Week

  • Maximum Ankle angle

    In Degrees. Kinematic parameter to define reliability

    One Week

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy adult volunteers

You may qualify if:

  • Age between 18 and 60 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CINEA

San Miguel de Tucumán, Tucumám, 4000, Argentina

Location

Study Officials

  • Bernardo Centeno

    Centro Integral de Neurologia y Especialidades Afines, Argentina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

October 20, 2022

Primary Completion

November 4, 2022

Study Completion

November 4, 2022

Last Updated

November 8, 2022

Record last verified: 2022-11

Locations