Hemiparetic StrokeOptiVisNCT06931509
Integration and Interactions Between Visual and Proprioceptive Feedbacks
A study testing Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov) in people with Hemiparetic Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Mental imagery is a rehabilitation technique for stroke patients, involving the mental representation of movement. Recent technical advancements have enabled the use of visual, proprioceptive, and mixed feedback to enhance motor stimulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparetic Stroke
- What is being tested?
- Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2025to 30 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic subjects : Male or female, aged 18 to 80 years, first ischemic or hemorrhagic stroke, having signed the written consent and affiliated or entitled to a social security scheme
Who cannot join
- Severe cognitive impairment, severe Aphasia or severe neglect that impair ability to understand instructions or to execute tasks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Saint-Etienne
Saint-Etienne, France, 42055
Diana Rimaud, doctor of science, 0477120467 ext. 33, Diana.Rimaud@chu-st-etienne.fr
Ahmed ADHAM, Md
About this study
Official title: Study of the Integration and Interactions Between Visual and Proprioceptive Feedbacks in Hemiplegic Patients
Mental imagery is a rehabilitation technique for stroke patients, involving the mental representation of movement. Recent technical advancements have enabled the use of visual, proprioceptive, and mixed feedback to enhance motor stimulation. Currently, all post-stroke patients receive these techniques indiscriminately. This study aims to demonstrate differences in the integration of visual and proprioceptive feedback in stroke patients and understand the determinants based on the affected brain area.
Patients with motor disabilities will perform motor imagery tasks with various feedback types while their cortical activity is recorded using EEG. EEG data for each type of feedback will be correlated with the lesion area in order to better understand the ongoing mechanisms.
- Conditions
- Hemiparetic Stroke
- Being tested
- Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)
- Keywords
- Computerize mirror, Vibration, Upper limb rehabilitation, Stroke, hemiplegic
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)Device
Visit 1 : Followed by 30 movements of Paretic arm wrist extension with 4 randomized experimental conditions (Vision alone, Vibration alone, Vision + Vibration, No feedback), with EEG monitoring. Measurement of movement perception feeling for each condition.
Visit 2 : 30 movements of Paretic arm wrist extension with 4 randomized experimental conditions (Vision alone, Vibration alone, Vision + Vibration, No feedback), with EEG monitoring. Measurement of movement perception feeling for each condition.
| Study group | Role | What they receive |
|---|---|---|
| Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov) | Experimental | During these sessions, they will perform a wrist extension task 30 times, under four different rehabilitation conditions (in randomized order), with pauses between conditions:
* Movement without feedback
* Movement with visual feedback
* Movement and vibratory feedback
* Movement with combined visual and vibratory feedback. Visual and vibratory feedback is provided using the IVS3 and Vibramoov Physio devices. Receives: Device: Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG beta desynchronization
Differences in the EEG beta desynchronization over motor-cortex across the types of feedbacks.
Measured: Day 1
Secondary outcomes (5)
Alpha Band
Alpha Band desynchronization over motor cortex
Measured: Day 1
Occipital alpha band
Occipital alpha band modulations
Measured: Day 1
Beta rebound
Beta rebound (Event related synchronization)
Measured: Day 1
Parietal beta-band
Parietal beta-band desynchronization
Measured: Day 1
Perception of movements
The intensity of the perception of movements using a visual analogue scale and the objective measurement of perceived movement angle reproduced by the healthy hand's and Visual analogic scale
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start25 Nov 2025
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparetic 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, Md, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06931509
- Sponsor's protocol ID
- 24CH167
- Other IDs
- 2024-A02163-44
- Acronym
- OptiVis
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is monocentric
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Integration and Interactions Between Visual and Proprioceptive Feedbacks in Hemiplegic Patients
- ClinicalTrials.gov ID
- NCT06931509
- Acronym / sponsor ID
- OptiVis / 24CH167
- Conditions
- Hemiparetic Stroke
- Keywords
- Computerize mirror, Vibration, Upper limb rehabilitation, Stroke, hemiplegic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 17 Apr 2025 (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.
Mental imagery is a rehabilitation technique for stroke patients, involving the mental representation of movement. Recent technical advancements have enabled the use of visual, proprioceptive, and mixed feedback to enhance motor stimulation. Currently, all post-stroke patients receive these techniques indiscriminately. This study aims to demonstrate differences in the integration of visual and proprioceptive feedback in stroke patients and understand the determinants based on the affected brain area.
Patients with motor disabilities will perform motor imagery tasks with various feedback types while their cortical activity is recorded using EEG. EEG data for each type of feedback will be correlated with the lesion area in order to better understand the ongoing mechanisms.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov) | Experimental | Device: Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)During these sessions, they will perform a wrist extension task 30 times, under four different rehabilitation conditions (in randomized order), with pauses between conditions: * Movement without feedback * Movement with visual feedback * Movement and vibratory feedback * Movement with combined visual and vibratory feedback. Visual and vibratory feedback is provided using the IVS3 and Vibramoov Physio devices. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hemiplegic subjects : Male or female, aged 18 to 80 years, first ischemic or hemorrhagic stroke, having signed the written consent and affiliated or entitled to a social security scheme
Key exclusion criteria (1 listed)
- Severe cognitive impairment, severe Aphasia or severe neglect that impair ability to understand instructions or to execute tasks
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 |
|---|---|---|
| Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov)Visit 1 : Followed by 30 movements of Paretic arm wrist extension with 4 randomized experimental conditions (Vision alone, Vibration alone, Vision + Vibration, No feedback), with EEG monitoring. Measurement of movement perception feeling for each condition. Visit 2 : 30 movements of Paretic arm wrist extension with 4 randomized experimental conditions (Vision alone, Vibration alone, Vision + Vibration, No feedback), with EEG monitoring. Measurement of movement perception feeling for each condition. | Device | Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov) |
Primary outcome
EEG beta desynchronization
Time frame: Day 1
Differences in the EEG beta desynchronization over motor-cortex across the types of feedbacks.
5 secondary outcomes
Alpha Band
Time frame: Day 1
Occipital alpha band
Time frame: Day 1
Beta rebound
Time frame: Day 1
Parietal beta-band
Time frame: Day 1
Perception of movements
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: Undecided. The study is monocentric
Related trials for Hemiparetic Stroke
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Optimal Targeted High-definition Transcranial Direct Current Stimulation for Reducing Post-stroke Upper Limb Motor Impairments
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Priming Theta Burst Stimulation for Stroke: A Study of Intensity
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Movement Amplification Gait Training to Enhance Walking Balance Post-Stroke
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Visual Stimulation Through Video Therapy to Enhance Lower Limb Motor Recovery After Stroke
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Structural Mechanisms of Dual-Target tDCS in Stroke Hemiparetic Hand
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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.
Pascal GIRAUX, Md principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized mirror therapy (IVS3) + Tendon vibration (Vibramoov) in people with Hemiparetic Stroke, run by Centre Hospitalier Universitaire de Saint Etienne 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 24 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Rimaud, doctor of science (0477120467 ext. 33, Diana.Rimaud@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG beta desynchronization (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.