Hemiparesis Clinical Trial
— SMART-REHABOfficial title:
Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
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 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Auxologico Italiano | Milan |
Lead Sponsor | Collaborator |
---|---|
Istituto Auxologico Italiano |
Italy,
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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