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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05801874
Other study ID # 21C130
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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