Clinical trial NCT04882930: Reproducibility of fNIRS Parameters During Walking
Official title: Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: fNIRS
reproductibility
stroke
gait
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 46
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy subjects, acute stroke patients, subacute stroke patients
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Oxyhemoglobin (HbO) variations during simple walking and during dual task
timeFrame: Day 0
measure: Deoxyhemoglobin (HbR) variations during simple walking and during dual task
timeFrame: Day 0
Secondary outcomes:
measure: Oxyhemoglobin (HbO) variations of acute stroke patients
timeFrame: Day 0
measure: Deoxyhemoglobin (HbR) variations of acute stroke patients
timeFrame: Day 0
measure: Oxyhemoglobin (HbO) variations of subacute stroke patients
timeFrame: Day 0
measure: Deoxyhemoglobin (HbR) variations of subacute stroke patients
timeFrame: Day 0
measure: Oxyhemoglobin (HbO) variations using different mathematical treatments.
timeFrame: Day 0
measure: Deoxyhemoglobin (HbR) variations using different mathematical treatments.
timeFrame: Day 0
Other outcomes:
Locations:
city: La Chapelle-Saint-Mesmin
country: France
facility: Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau
city: Limoges
country: France
facility: Chu Limoges
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR d'Orléans
name: Andreea AIGNATOAIE
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.