Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation

NCT05801874 | Unknown

• 1 other identifier: 21C130
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. Device as single Microsoft sensor Kinect v2, wearable sensorized clothing and/or smartphone-type devices will be used; it is also planned to analyze and compare such parameters with those obtained through a technique of manual palpatory analysis. Finally the obtained measures will be compared with the corresponding ones obtained with Three-dimensional instrumented gait analysis (3D-GA).

Conditions

Stroke Sequelae; Hemiparesis; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (1)

• GPS (Gait Profile Score index) - differences between techniques

  % of agreement between 3D-GA (3 dimensional Gait Analysis - optoelectronic system) and Kinect motion analysis in the detection of kinematic data about gait collected within the GPS (Gait Profile Score Index)

  During movement analysis

Secondary Outcomes (1)

• Gait cycle values (stance and swing duration) - differences between techniques

  During movement analysis

Study Arms (2)

Hemiparetic patients

Hemiparetic patients assessed during gait and stance performance by means of different instrumental tools (smart and portable device vs 3D laboratory gait analysis) in order to evidence gait pattern; kinematics, kinetics and spatio-temporal data.

Diagnostic Test: Movement analysis

Healthy age matched subjects

Healthy age matched subjects assessed during gait and stance performance by means of different instrumental tools (smart and portable device vs 3D laboratory gait analysis) in order to evidence gait pattern; kinematics, kinetics and spatio-temporal data.

Diagnostic Test: Movement analysis

Interventions

Movement analysis DIAGNOSTIC_TEST

Qualitative and quantitative computerized and instrumental assessment of gait and posture.

Healthy age matched subjects; Hemiparetic patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Single laboratory movement analysis with different tools and tecniques

You may qualify if:

• patient with post-stroke chronic hemiparesis (at least 6 month post-acute event)
• ability to stand erect for 30 seconds
• ability to walk with or without aids for 10 meters

You may not qualify if:

• Moderate/severe cognitive impairment (MMSE \< 22)
• Moderate/severe depression (Hamilton Depression Scale \> 20)
• Severe spasticity

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Paresis; Gait Disorders, Neurologic

Interventions

Eye-Tracking Technology

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Eye Movement Measurements; Diagnostic Techniques, Ophthalmological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Matteo Bigoni, MD

  Istituto Auxologico Italiano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matteo Bigoni, MD

CONTACT

+390323514445; m.bigoni@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2023
• First Posted: April 6, 2023
• Study Start: September 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-03

Locations

IT (1)