Reproducibility of fNIRS Parameters During Walking

Stroke Clinical Trial

— REPROXY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882930
• Other study ID #: CHRO-2020-23
• Status: Recruiting
• Phase: N/A
• Start date: June 29, 2021
• Est. completion date: June 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: Andreea AIGNATOAIE
• Phone: 0238229947
• Email: andreea.aignatoiae[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau	La Chapelle-Saint-Mesmin
France	Chu Limoges	Limoges
France	CHR Orléans	Orléans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxyhemoglobin (HbO) variations during simple walking and during dual task	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.	Day 0
Primary	Deoxyhemoglobin (HbR) variations during simple walking and during dual task	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.	Day 0
Secondary	Oxyhemoglobin (HbO) variations of acute stroke patients		Day 0
Secondary	Deoxyhemoglobin (HbR) variations of acute stroke patients		Day 0
Secondary	Oxyhemoglobin (HbO) variations of subacute stroke patients		Day 0
Secondary	Deoxyhemoglobin (HbR) variations of subacute stroke patients		Day 0
Secondary	Oxyhemoglobin (HbO) variations using different mathematical treatments.		Day 0
Secondary	Deoxyhemoglobin (HbR) variations using different mathematical treatments.		Day 0