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Completed

NCT Number: NCT04882930

Reproducibility of fNIRS Parameters During Walking

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau, La Chapelle-Saint-Mesmin, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Near-Infrared Spectroscopy (fNIRS)

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Oxyhemoglobin (HbO) variations of acute stroke patients

    Time frame: Day 0

  2. Deoxyhemoglobin (HbR) variations of acute stroke patients

    Time frame: Day 0

  3. Oxyhemoglobin (HbO) variations of subacute stroke patients

    Time frame: Day 0

  4. Deoxyhemoglobin (HbR) variations of subacute stroke patients

    Time frame: Day 0

  5. Oxyhemoglobin (HbO) variations using different mathematical treatments.

    Time frame: Day 0

  6. Deoxyhemoglobin (HbR) variations using different mathematical treatments.

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: REPROXY

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 12, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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