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

March 24, 2023 updated by: Istituto Auxologico Italiano
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Recruiting
        • Istituto Auxologico Italiano
        • Contact:
          • Matteo Bigoni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Single laboratory movement analysis with different tools and tecniques

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GPS (Gait Profile Score index) - differences between techniques
Time Frame: 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)
During movement analysis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait cycle values (stance and swing duration) - differences between techniques
Time Frame: 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)
During movement analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

February 26, 2023

First Submitted That Met QC Criteria

March 24, 2023

First Posted (Actual)

April 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2023

Last Update Submitted That Met QC Criteria

March 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21C130

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke Sequelae

Clinical Trials on Movement analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe