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

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05801874
Collaborator
(none)
24
1
24
1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Movement analysis

Study Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Gait and Posture Analysis in Hemiparetic Patients Through Optoelectronic Systems, "Smart" Tools and Clinical Evaluation
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
Qualitative and quantitative computerized and instrumental assessment of gait and posture.

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istituto Auxologico Italiano Milan Italy 20145

Sponsors and Collaborators

  • Istituto Auxologico Italiano

Investigators

  • Principal Investigator: Matteo Bigoni, MD, Istituto Auxologico Italiano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05801874
Other Study ID Numbers:
  • 21C130
First Posted:
Apr 6, 2023
Last Update Posted:
Apr 6, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2023