Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients (KAPP-IMU)

September 11, 2023 updated by: Centre Hospitalier Universitaire Dijon
Stroke is the leading cause of acquired disability in adults in France, and more than 500,000 French people are currently living with the after-effects. Hemiparesis, which is a partial deficit of motor or muscular control affecting the right or left half of the body, is the most frequent motor disorder after a stroke. Currently, the management and treatment of stroke patients consists of a combination of pharmacological treatments (drugs, botulinum toxin, etc.), the fitting of devices (orthoses, etc.) and rehabilitation (physical therapy, adapted physical activity, occupational therapy, etc.). According to the French National Authority for Health, motor rehabilitation after a stroke must meet 3 criteria: early, intensive and continuous. Functional evaluations (with validated measurement scales or analysis of locomotor activities) make it possible to monitor rehabilitation and to verify that the intensity is adapted to the patient's needs. To date, technological advances have yielded numerous gait analysis devices, ranging from motion capture platforms to inertial measurement units (IMU) and the use of motion platforms with integrated sensors. Different systems embedding an IMU on the foot, for example, answer these problems of analysis of walking in real situation. The IMUs record the movements and orientation of the foot in space; the data are then processed by algorithms to recognize the walking steps and calculate the spatiotemporal locomotion parameters. Additional IMUs positioned on the body can be added to this system in order to access a more precise analysis of locomotion, in particular by calculating the movements of the various joints of the lower limb. The validation of systems integrating IMUs must be done according to a precise method widely documented by the COSMIN recommendations (COnsensus-based Standards for the selection of health Measurement INstruments). This project will be carried out in two stages, the first of which will evaluate the safety and psychometric properties of the spatiotemporal parameters of the IMU devices in healthy subjects. If these properties (safety, reproducibility and validity) are considered to be in conformity, the second phase will be initiated. These same parameters will be evaluated during the rehabilitation of a cohort of patients who have suffered a stroke.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy volunteers:
  • Person who has given oral consent
  • man or woman 18 years or older
  • a person who is able to understand simple orders, instructions for locomotion
  • person living within a maximum radius of 50 km from the investigation site

Patients (in addition to the above):

  • persons who have had a stroke of any origin in the last 6 months
  • person included in a rehabilitation protocol

Exclusion Criteria:

  • persons who are not affiliated to national health insurance
  • persons subject to a legal protection measure (guardianship)
  • persons who are subject to a legal protection measure
  • pregnant women
  • adult unable to express consent
  • subject with a disarticulated hip
  • Subjects with diseases or disabilities that have an impact on walking other than those related to the stroke.

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients after a Stroke
Other: Analysis of the walk
Gait analysis in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Patients: S0, S1, S2, S4 and S6 Healthy volunteers: 2 times (between 3 and 20 days apart)
Active Comparator: Healthy Volunteering
Other: Analysis of the walk
Gait analysis in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Patients: S0, S1, S2, S4 and S6 Healthy volunteers: 2 times (between 3 and 20 days apart)
Other: Analysis of the race
Analysis of running in 3 dimensions and with inertial measurement units (IMUs) on flat ground and motorized treadmill Healthy volunteers: 2 times (between 3 and 20 days apart)
Other: Unipodal and bipodal jumps on flat ground
Healthy volunteers: 2 times (between 3 and 20 days apart)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Walking speed
Time Frame: Patients: Change from baseline at week 6
Patients: Change from baseline at week 6
Walking speed
Time Frame: Healthy volunteers: Change from baseline at 20 days after inclusion
Healthy volunteers: Change from baseline at 20 days after inclusion

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 29, 2021

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

November 3, 2021

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORNETTI DIGITSOLE 2021

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.

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