StrokeBIROBONIRSNCT06116006
fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects
A study testing Upper limb pointing movements in 3 experimental conditions in people with Stroke and Healthy, run by Clinique Les Trois Soleils at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Upper limb pointing movements in 3 experimental conditions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to 2 Feb 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 21Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Upper limb pointing movements in 3 experimental conditions
- Keywords
- stroke, upper limb, robot-based therapy, physical modalities, effort, fnirs, cortical activation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper limb pointing movements in 3 experimental conditionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with 3 experimental conditions | Other | 3 types of upper limb pointing movements:
* movements with robot assistance
* movements without robot assistance
* movements with robot resistance Receives: Other: Upper limb pointing movements in 3 experimental conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of oxyhemoglobin concentration during upper limb tasks
Measured: Day 0
Change of desoxyhemoglobin concentration during upper limb tasks
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 posted3 Nov 2023
- Study start15 Jan 2024
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Les Trois Soleils
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional d'Orléans
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116006
- Sponsor's protocol ID
- 2022-A02827-36
- Acronym
- BIROBONIRS
- Status last verified
- Mar 2026
- First submitted
- 30 Oct 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shi P, Li A, Yu H. Response of the Cerebral Cortex to Resistance and Non-resistance Exercise Under Different Trajectories: A Functional Near-Infrared Spectroscopy Study. Front Neurosci. 2021 Oct 13;15:685920. doi: 10.3389/fnins.2021.685920. eCollection 2021.
PubMed 34720845Zheng J, Shi P, Fan M, Liang S, Li S, Yu H. Effects of passive and active training modes of upper-limb rehabilitation robot on cortical activation: a functional near-infrared spectroscopy study. Neuroreport. 2021 Apr 7;32(6):479-488. doi: 10.1097/WNR.0000000000001615.
PubMed 33788815
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fNIRS Study of Effort-dependent Brain Activations During Pointing Movements of the Upper Limb in Post-stroke Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT06116006
- Acronym / sponsor ID
- BIROBONIRS / 2022-A02827-36
- Keywords
- stroke, upper limb, robot-based therapy, physical modalities, effort, fnirs, cortical activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Clinique Les Trois SoleilsUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional d'Orléans
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 3 Nov 2023 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with 3 experimental conditions | Other | Other: Upper limb pointing movements in 3 experimental conditions3 types of upper limb pointing movements: * movements with robot assistance * movements without robot assistance * movements with robot resistance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Upper limb pointing movements in 3 experimental conditionsRecording 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. | Other | Subjects with 3 experimental conditions |
Primary outcome
Change of oxyhemoglobin concentration during upper limb tasks
Time frame: Day 0
Change of desoxyhemoglobin concentration during upper limb tasks
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 18 Mar 2026.
- Background: PubMed 34720845Shi P, Li A, Yu H. Response of the Cerebral Cortex to Resistance and Non-resistance Exercise Under Different Trajectories: A Functional Near-Infrared Spectroscopy Study. Front Neurosci. 2021 Oct 13;15:685920. doi: 10.3389/fnins.2021.685920. eCollection 2021.
- Background: PubMed 33788815Zheng J, Shi P, Fan M, Liang S, Li S, Yu H. Effects of passive and active training modes of upper-limb rehabilitation robot on cortical activation: a functional near-infrared spectroscopy study. Neuroreport. 2021 Apr 7;32(6):479-488. doi: 10.1097/WNR.0000000000001615.
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper limb pointing movements in 3 experimental conditions in people with Stroke and Healthy, run by Clinique Les Trois Soleils at 1 site 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 21 inclusion and 0 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change of oxyhemoglobin concentration during upper limb tasks (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 NCT06116006, which also lists 2 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 18 Mar 2026.