StrokeREPROXYNCT04882930
Reproducibility of fNIRS Parameters During Walking
A study testing Functional Near-Infrared Spectroscopy (fNIRS) in people with Stroke, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Near-Infrared Spectroscopy (fNIRS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesFrance
- Study dates
- 29 Jun 2021to 8 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 10Show fewer
- 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 locations and contacts
3 sites in 1 country.
France3 sites
Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau
La Chapelle-Saint-Mesmin
Chu Limoges
Limoges
CHR Orléans
Orléans, 45067
About this study
Official title: Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Functional Near-Infrared Spectroscopy (fNIRS)
- Keywords
- fNIRS, reproductibility, stroke, gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Near-Infrared Spectroscopy (fNIRS)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Near-Infrared Spectroscopy (fNIRS) acquisitions | Experimental | 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. Receives: Procedure: Functional Near-Infrared Spectroscopy (fNIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
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.
Measured: Day 0
Secondary outcomes (6)
Oxyhemoglobin (HbO) variations of acute stroke patients
Measured: Day 0
Deoxyhemoglobin (HbR) variations of acute stroke patients
Measured: Day 0
Oxyhemoglobin (HbO) variations of subacute stroke patients
Measured: Day 0
Deoxyhemoglobin (HbR) variations of subacute stroke patients
Measured: Day 0
Oxyhemoglobin (HbO) variations using different mathematical treatments.
Measured: Day 0
Deoxyhemoglobin (HbR) variations using different mathematical treatments.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start29 Jun 2021
- Primary completion8 Sep 2023
- Study completion8 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Healthy subjects, acute stroke patients, subacute stroke patients
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreea AIGNATOAIE, Principal investigator, CHR d'Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882930
- Sponsor's protocol ID
- CHRO-2020-23
- Acronym
- REPROXY
- Status last verified
- Aug 2024
- First submitted
- 15 Apr 2021
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31312136Hawkins 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.
PubMed 29604488Holden 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.
PubMed 6691052Pelicioni 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.
PubMed 31110922
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of fNIRS Parameters During Walking in Stroke Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT04882930
- Acronym / sponsor ID
- REPROXY / CHRO-2020-23
- Conditions
- Stroke
- Keywords
- fNIRS, reproductibility, stroke, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 8 Sep 2023 (actual)
- Study completion
- 8 Sep 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy subjects, acute stroke patients, subacute stroke patients
| Arm | Type | Receives |
|---|---|---|
| Functional Near-Infrared Spectroscopy (fNIRS) acquisitions | Experimental | Procedure: 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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute stroke group, subacute stroke group, and control group:
- Acute Stroke and Subacute Stroke Group:
Key exclusion criteria (10 listed)
- Acute stroke group, subacute stroke group, and control group:
- Acute stroke group and subacute stroke group:
- Control group: neurological medical history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Functional Near-Infrared Spectroscopy (fNIRS) acquisitions |
Primary outcome
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.
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.
6 secondary outcomes
Oxyhemoglobin (HbO) variations of acute stroke patients
Time frame: Day 0
Deoxyhemoglobin (HbR) variations of acute stroke patients
Time frame: Day 0
Oxyhemoglobin (HbO) variations of subacute stroke patients
Time frame: Day 0
Deoxyhemoglobin (HbR) variations of subacute stroke patients
Time frame: Day 0
Oxyhemoglobin (HbO) variations using different mathematical treatments.
Time frame: Day 0
Deoxyhemoglobin (HbR) variations using different mathematical treatments.
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 31312136Hermand 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.
- Background: PubMed 29604488Hawkins 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.
- Background: PubMed 6691052Holden 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.
- Background: PubMed 31110922Pelicioni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreea AIGNATOAIE principal investigator
CHR d'Orléans
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Near-Infrared Spectroscopy (fNIRS) in people with Stroke, run by Centre Hospitalier Régional d'Orléans at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxyhemoglobin (HbO) variations during simple walking and during dual task (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04882930, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.