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Reproducibility of fNIRS Parameters During Walking (REPROXY)

C

Centre Hospitalier Régional d'Orléans

Status

Completed

Conditions

Stroke

Treatments

Procedure: Functional Near-Infrared Spectroscopy (fNIRS)

Study type

Interventional

Funder types

Other

Identifiers

NCT04882930
CHRO-2020-23

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

Functional Near-Infrared Spectroscopy (fNIRS) acquisitions
Experimental group
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.
Treatment:
Procedure: Functional Near-Infrared Spectroscopy (fNIRS)

Trial contacts and locations

3

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Central trial contact

Andreea AIGNATOAIE; Fabrice PRIEUR

Data sourced from clinicaltrials.gov

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