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

Recruiting

• Conditions: Stroke Sequelae; Hemiparesis; Gait Disorders, Neurologic
• Interventions: Diagnostic Test: Movement analysis

• Registration Number: NCT05801874
• Lead Sponsor: Istituto Auxologico Italiano

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2023-02-26
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-24
• Last Update Submitted: 2023-03-24
• Study First Posted: 2023-04-06
• Last Update Posted: 2023-04-06
• Primary Completion: 2023-09-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemiparetic patients	Movement analysis	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.
Healthy age matched subjects	Movement analysis	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.

Primary Outcome Measures

Name	Time	Method
GPS (Gait Profile Score index) - differences between techniques	During movement analysis	% 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)

Secondary Outcome Measures

Name	Time	Method
Gait cycle values (stance and swing duration) - differences between techniques	During movement analysis	% of agreement between 3D-GA (3 dimensional Gait Analysis - optoelectronic system) and Kinect motion analysis in the detection of Gait cycle values (stance and swing duration)

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milan, Italy