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

Hemiparesis Clinical Trial

— SMART-REHAB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05801874
• Other study ID #: 21C130
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2023
• Source: Istituto Auxologico Italiano
• Contact: Matteo Bigoni, MD
• Phone: +390323514445
• Email: m.bigoni[@]auxologico.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Hemiparesis
• Nervous System Diseases
• Paresis
• Stroke Sequelae

Intervention

Diagnostic Test:
• Movement analysis
Qualitative and quantitative computerized and instrumental assessment of gait and posture.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gait cycle values (stance and swing duration) - differences between techniques	% 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)	During movement analysis