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Reproducibility of fNIRS Parameters During Walking (REPROXY)

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Near-Infrared Spectroscopy (fNIRS)
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke focused on measuring fNIRS, reproductibility, stroke, gait

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre de Réadaptation Fonctionnelle et d'Appareillage Le CoteauRecruiting
  • Chu LimogesRecruiting
  • CHR OrléansRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Functional Near-Infrared Spectroscopy (fNIRS) acquisitions

Arm Description

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.

Outcomes

Primary Outcome Measures

Oxyhemoglobin (HbO) variations during simple walking and during dual task
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.
Deoxyhemoglobin (HbR) variations during simple walking and during dual task
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.

Secondary Outcome Measures

Oxyhemoglobin (HbO) variations of acute stroke patients
Deoxyhemoglobin (HbR) variations of acute stroke patients
Oxyhemoglobin (HbO) variations of subacute stroke patients
Deoxyhemoglobin (HbR) variations of subacute stroke patients
Oxyhemoglobin (HbO) variations using different mathematical treatments.
Deoxyhemoglobin (HbR) variations using different mathematical treatments.

Full Information

First Posted
April 15, 2021
Last Updated
July 19, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT04882930
Brief Title
Reproducibility of fNIRS Parameters During Walking
Acronym
REPROXY
Official Title
Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
fNIRS, reproductibility, stroke, gait

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Healthy subjects, acute stroke patients, subacute stroke patients
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional Near-Infrared Spectroscopy (fNIRS) acquisitions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Functional Near-Infrared Spectroscopy (fNIRS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Oxyhemoglobin (HbO) variations during simple walking and during dual task
Description
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.
Time Frame
Day 0
Title
Deoxyhemoglobin (HbR) variations during simple walking and during dual task
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Oxyhemoglobin (HbO) variations of acute stroke patients
Time Frame
Day 0
Title
Deoxyhemoglobin (HbR) variations of acute stroke patients
Time Frame
Day 0
Title
Oxyhemoglobin (HbO) variations of subacute stroke patients
Time Frame
Day 0
Title
Deoxyhemoglobin (HbR) variations of subacute stroke patients
Time Frame
Day 0
Title
Oxyhemoglobin (HbO) variations using different mathematical treatments.
Time Frame
Day 0
Title
Deoxyhemoglobin (HbR) variations using different mathematical treatments.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andreea AIGNATOAIE
Phone
0238229947
Email
andreea.aignatoiae@chr-orleans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice PRIEUR
Email
fabrice.prieur@univ-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreea AIGNATOAIE
Organizational Affiliation
CHR d'Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau
City
La Chapelle-Saint-Mesmin
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassal BAZZI, Dr
First Name & Middle Initial & Last Name & Degree
Hassal BAZZI, Dr
Facility Name
Chu Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maxence COMPAGNAT, Dr
First Name & Middle Initial & Last Name & Degree
Maxence COMPAGNAT, Dr
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreea AIGNATOAIE
Phone
+33 2 38 22 99 47
Email
andreea.aignatoaie@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Andreea AIGNATOAIE

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31312136
Citation
Hermand E, Tapie B, Dupuy O, Fraser S, Compagnat M, Salle JY, Daviet JC, Perrochon A. Prefrontal Cortex Activation During Dual Task With Increasing Cognitive Load in Subacute Stroke Patients: A Pilot Study. Front Aging Neurosci. 2019 Jul 2;11:160. doi: 10.3389/fnagi.2019.00160. eCollection 2019.
Results Reference
background
PubMed Identifier
29604488
Citation
Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:46-55. doi: 10.1016/j.humov.2018.03.010. Epub 2018 Mar 29.
Results Reference
background
PubMed Identifier
6691052
Citation
Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.
Results Reference
background
PubMed Identifier
31110922
Citation
Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019.
Results Reference
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Reproducibility of fNIRS Parameters During Walking

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