Reproducibility of fNIRS Parameters During Walking

NCT ID: NCT04882930

Last Updated: 2024-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-29

Study Completion Date

2023-09-08

Brief Summary

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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

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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.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Healthy subjects, acute stroke patients, subacute stroke patients
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Functional Near-Infrared Spectroscopy (fNIRS)

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andreea AIGNATOAIE

Role: PRINCIPAL_INVESTIGATOR

CHR d'Orléans

Locations

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Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau

La Chapelle-Saint-Mesmin, , France

Site Status

Chu Limoges

Limoges, , France

Site Status

CHR Orléans

Orléans, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 31312136 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29604488 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 6691052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31110922 (View on PubMed)

Other Identifiers

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CHRO-2020-23

Identifier Type: -

Identifier Source: org_study_id

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