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Reproducibility of fNIRS Parameters During Walking

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04882930
Acronym
REPROXY
Enrollment
46
Registered
2021-05-12
Start date
2021-06-29
Completion date
2023-09-08
Last updated
2024-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

fNIRS, reproductibility, stroke, gait

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.

Interventions

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.

Sponsors

Centre Hospitalier Régional d'Orléans
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Healthy subjects, acute stroke patients, subacute stroke patients

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Oxyhemoglobin (HbO) variations during simple walking and during dual taskDay 0HbO 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 taskDay 0HbR 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

MeasureTime frame
Oxyhemoglobin (HbO) variations of subacute stroke patientsDay 0
Deoxyhemoglobin (HbR) variations of subacute stroke patientsDay 0
Oxyhemoglobin (HbO) variations of acute stroke patientsDay 0
Deoxyhemoglobin (HbR) variations using different mathematical treatments.Day 0
Oxyhemoglobin (HbO) variations using different mathematical treatments.Day 0
Deoxyhemoglobin (HbR) variations of acute stroke patientsDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026