Reproducibility of fNIRS Parameters During Walking (REPROXY)

August 1, 2024 updated by: Centre Hospitalier Régional d'Orléans

Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects

Brain activation can be studied using the Functional Near InfraRed Spectroscopy (fNIRS). It was shown that CPF activation during walking and during dual task could be different in stroke patients and in healthy subjects.

To date, fNIRS reliability is not completely established during walking and during dual task. Therefore, this study will examine the reproducibility of fNIRS parameters during simple walking and during dual task in healthy subjects and in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A fNIRS system will be used to measure the CPF activation. The subjects will walk at their preferred speed on 10 m 3 times and while doing a cognitive task (dual task) 3 times also (in a random order). The same test will be repeated five minutes later. The fNIRS system will be retired and the same test will be repeated 10 min later.

Study Type

Interventional

Enrollment (Actual)

46

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 Locations

  • France
      • La Chapelle-Saint-Mesmin, France
        • Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau
      • Limoges, France
        • CHU Limoges
      • Orléans, France, 45067
        • CHR Orléans

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

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Acute stroke group, subacute stroke group, and control group:

    • Age 50 to 80 years
    • Affiliated with a social security plan
    • Able to walk 20 meters unassisted

  • Acute Stroke and Subacute Stroke Group:

    • Stroke onset less than 14 days (for the acute stroke group) or between 14 days and 6 months (for the subacute stroke group)
    • Stroke located in the left or right middle cerebral artery.

Exclusion Criteria:

  • Acute stroke group, subacute stroke group, and control group:

    • Person under guardianship or curatorship
    • Refusal to sign informed consent
    • Known rheumatologic or cardiologic history
    • Medication that alters the vigilance and may affect walking (high dose psychotropic drugs, antispastic drugs).

  • Acute stroke group and subacute stroke group:

    • History of symptomatic stroke
    • Previous neurological disease limiting gait, aphasia or impaired cognitive function (mild cognitive dementia, Alzheimer's or Parkinson's disease)
    • Ambulatory functional category < 3
  • Control group: neurological medical history

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Functional Near-Infrared Spectroscopy (fNIRS) acquisitions
The hemodynamic response in CPF will be measured using an Octomon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.
Procedure: Functional Near-Infrared Spectroscopy (fNIRS)
All participants will undergo Functional Near-Infrared Spectroscopy (fNIRS). The hemodynamic response in CPF will be measured using an Octomon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxyhemoglobin (HbO) variations during simple walking and during dual task
Time Frame: Day 0
HbO will be measured by the NIR spectrometry technique continuously at rest and during walking. This technique allows to measure the variations of HbO concentration by measuring the variations of light absorption by the explored tissues.
Day 0
Deoxyhemoglobin (HbR) variations during simple walking and during dual task
Time Frame: Day 0
HbR will be measured by the NIR spectrometry technique continuously at rest and during walking. This technique allows to measure the variations of HbR concentration by measuring the variations of light absorption by the explored tissues.
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
Oxyhemoglobin (HbO) variations of acute stroke patients
Time Frame: Day 0
Day 0
Deoxyhemoglobin (HbR) variations of acute stroke patients
Time Frame: Day 0
Day 0
Oxyhemoglobin (HbO) variations of subacute stroke patients
Time Frame: Day 0
Day 0
Deoxyhemoglobin (HbR) variations of subacute stroke patients
Time Frame: Day 0
Day 0
Oxyhemoglobin (HbO) variations using different mathematical treatments.
Time Frame: Day 0
Day 0
Deoxyhemoglobin (HbR) variations using different mathematical treatments.
Time Frame: Day 0
Day 0

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Andreea AIGNATOAIE, CHR d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 29, 2021

Primary Completion (Actual)

September 8, 2023

Study Completion (Actual)

September 8, 2023

Study Registration Dates

First Submitted

April 15, 2021

First Submitted That Met QC Criteria

May 11, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2020-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

Clinical Trials on Functional Near-Infrared Spectroscopy (fNIRS)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe