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

Primary Purpose

Cerebral Vascular Accident

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Analysis of the walk
Analysis of the race
Unipodal and bipodal jumps on flat ground
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cerebral Vascular Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chu Dijon BourgogneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Patients after a Stroke

Healthy Volunteering

Arm Description

Outcomes

Primary Outcome Measures

Walking speed
Walking speed

Secondary Outcome Measures

Full Information

First Posted
September 27, 2021
Last Updated
September 11, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT05104645
Brief Title
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients
Acronym
KAPP-IMU
Official Title
Analysis of the Psychometric Properties of Kinematic Parameters of Locomotion Measured by Inertial Units. Validation in Healthy Volunteers and Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 29, 2021 (Actual)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Vascular Accident

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients after a Stroke
Arm Type
Experimental
Arm Title
Healthy Volunteering
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Analysis of the walk
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Analysis of the race
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Unipodal and bipodal jumps on flat ground
Intervention Description
Healthy volunteers: 2 times (between 3 and 20 days apart)
Primary Outcome Measure Information:
Title
Walking speed
Time Frame
Patients: Change from baseline at week 6
Title
Walking speed
Time Frame
Healthy volunteers: Change from baseline at 20 days after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul ORNETTI
Phone
03 80 29 38 72
Email
paul.ornetti@chu-dijon.fr
Facility Information:
Facility Name
Chu Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu GUEUGNON
Phone
03 80 29 38 72
Email
mathieu.gueugnon@chu-dijon.fr

12. IPD Sharing Statement

Learn more about this trial

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

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