fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects (BIROBONIRS)

March 16, 2026 updated by: Clinique Les Trois Soleils

Background: Following a stroke, as part of neurorehabilitation, the intensity of effort is important to promote neural changes and stimulate motor recovery. There are few studies concerning the cortical activity involved at different levels of intensity during upper limb motor training.

Objective: To investigate cortex activation while walking an exoskeleton with 4 levels of guidance force in healthy controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Upper limb paresis is the most common motor deficit following a stroke, and its long-term persistence has an impact on patients' functional recovery and quality of life. Rehabilitation is therefore a major challenge in restoring functional independence.

New physical treatments have been developed over the last 20 years to optimize motor relearning by intensifying motor rehabilitation; among them, therapy using robotic devices has shown its effectiveness in reducing motor deficits.

This therapy offers various options ranging from assistance to movement resistance, which modulates the intensity of effort required of patients during target-pointing exercises.

The brain mechanisms involved in this type of rehabilitation remains imperfectly understood.

Functional neuroimaging techniques such as magnetic resonance imaging (fMRI), positron emission tomography (PET) and functional near-infrared spectroscopy (fNIRS) provide important information on brain activation induced by external stimuli. Among these, fNIRS is a non-invasive method for measuring hemodynamic responses associated with activation of the cerebral cortex. It enables the study of cerebral neurovascular coupling, and is based on the fact that an activated cerebral region increases its oxygen consumption and thus local blood volume and flow.

A better understanding of the cortical effects resulting from the physical forces applied to the upper limb could help optimize the rehabilitation treatment of patients, thereby promoting cerebral plasticity.The aim of the study is to compare cortical responses measured by fNIRS during 3 types of upper limb pointing movement:

  • robot-assisted movements
  • robot-unassisted movements
  • robot-resisted movements

in patients with chronic hemiparesis after stroke and in healthy subjects.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Boissise-le-Roi, France, 77310
        • La Clinique Les Trois Soleils

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

INCLUSION CRITERIA

For stroke subjects

  • Age ≥18 years;
  • Stroke-induced hemiparesis, chronic phase (>6 months post-stroke);
  • Moderate upper limb paresis defined by an upper limb FMA score 20 pts < FMA score < 47 pts ;
  • Right-handed patient;
  • Patient having agreed to sign an informed consent form;
  • Patient affiliated to the French social security system.

For healthy subjects

  • Age-matched participant, for each stroke subject included will be associated a control subject of the same age (to the nearest 5 years);
  • Right-handed participant;
  • Participant having agreed to sign an informed consent form;
  • Participant affiliated to the French social security system.

NON-INCLUSION CRITERIA

For stroke subjects

  • Cognitive impairment making participation in the study impossible;
  • Phasic disorders preventing comprehension of instructions and effective communication.

For healthy subjects

  • Pathology of the dominant upper limb;
  • Cognitive disorders making participation in the study impossible;
  • Presence of labelled or unlabelled neurological disorders;
  • Persons under legal protection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects with 3 experimental conditions

3 types of upper limb pointing movements:

  • movements with robot assistance
  • movements without robot assistance
  • movements with robot resistance
Other: Upper limb pointing movements in 3 experimental conditions
Recording of cerebral hemodynamic with fNIRS during upper limb pointing movements with a robotic device in three conditions: movements with robot assistance, movements without robot assistance and movements with robot resistance. Each subject are recorded during 6 trials for each condition (18 trials). The order is counterbalanced among the subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of oxyhemoglobin concentration during upper limb tasks
Time Frame: Day 0
Day 0
Change of desoxyhemoglobin concentration during upper limb tasks
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Les Trois Soleils

Collaborators

Centre Hospitalier Régional d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

February 2, 2024

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

October 30, 2023

First Posted (Actual)

November 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-A02827-36

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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