StrokeSI-VIMNCT04025411
Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.
A study testing Intensive Visual Simulation 3 (IVS3) device, traditional Mirror Therapy (TM) and Electroencephalography (EEG) in people with Stroke, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Intensive Visual Simulation 3 (IVS3) device, traditional Mirror Therapy (TM) and Electroencephalography (EEG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2019to 6 Jul 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First ischemic or hemorrhagic stroke for less than one year
- Not having reoffend
- Responsible for an initially complete hemiplegia,
- Upper-limb deficiency with the modified Frenchay Score below 70,
- Not neurological history other than stroke,
- Having signed the written consent
- Affiliated or entitled to a social security scheme
Who cannot join
- Patient who have not Magnetic Resonance Images (MRI) of the brain during stroke
- Having complete lesion of the primary motor cortex
- With an addiction to alcohol or drugs
- With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignancy, severe renal or pulmonary impairment
- History of associated disabling general disease
- With associated cerebellar syndrome
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- With clinical involvement of the brainstem
- Pregnancy in progress
- Patients under the protection of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view.
A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.
Read the detailed description
The aim of this study is to compare the observance and efficiency of the Intensive Visual Simulation 3 (IVS3) therapy as compared to traditional Mirror Therapy (TM) in a population of hemiplegic stroke patients.
- Conditions
- Stroke
- Being tested
- Intensive Visual Simulation 3 (IVS3) device, traditional Mirror Therapy (TM), Electroencephalography (EEG)
- Keywords
- Stroke, Upper limb rehabilitation, Computerized mirror therapy, Hemiparetic, Mirror therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Visual Simulation 3 (IVS3) deviceDevice
Also called Computerized Mirror Therapy (TM) device
Visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
The patient looks on a screen in front of him, mirroring the movements made by his healthy hand, while attempting to perform the same movement with his paretic hand.
traditional Mirror Therapy (TM)Device
Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
Electroencephalography (EEG)Device
Electroencephalography (EEG) will be performed during the 1st, 6th, 11th, 16th and 20th session of their programme will be made in order to evaluate brain activity.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patient with stroke ischemic or hemorrhagic will be included. They will have visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device and electroencephalography (EEG). Receives: Device: Intensive Visual Simulation 3 (IVS3) device; Device: Electroencephalography (EEG) |
| Control group | Active comparator | Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG). Receives: Device: traditional Mirror Therapy (TM); Device: Electroencephalography (EEG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
Measured by Fugl-Meyer motor assessment score at baseline, at 18 days, at 32 days, and at 60 days.
Fugl-Meyer score assesses the analytical motor skills of the upper limb with minimum score at 0 (hemiplegia) and maximum score at 66 (normal motor performance).
Measured: Day: 0, 18, 32, 60
Secondary outcomes (4)
Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.
Measured by Frenchay Arm Test score at baseline, at 18 days, at 32 days, and at 60 days.
Frenchay Arm Test score assesses functional improvement of the activities of the upper limb paretics with minimum score at 0 (total dependence) and maximum score at 100 (complete autonomy).
Measured: Day: 0, 18, 32, 60
Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.
Measured by Barthel index at baseline, at 18 days, at 32 days, and at 60 days. Barthel index assesses autonomy with minimum score at 0 (total dependence) and maximum score at 100 (complete autonomy).
Measured: Day: 0, 18, 32, 60
Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.
Measured by Abilhand questionnaire at baseline, at 18 days, at 32 days, and at 60 days.
Abilhand questionnaire will allow self-evaluation of the function of the upper limb in daily life with minimum score at 0 (difficulties in daily life) and maximum score at 46 (no difficulties in daily life).
Measured: Day: 0, 18, 32, 60
Analysis of brain activity
Measured by Electroencephalography (EEG) results.
Measured: Month: 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start28 Oct 2019
- Primary completion3 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Saint-Etienne Métropole
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04025411
- Sponsor's protocol ID
- 18CH200
- Other IDs
- 2019-A00041-56
- Acronym
- SI-VIM
- Status last verified
- Apr 2024
- First submitted
- 17 Jul 2019
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
- ClinicalTrials.gov ID
- NCT04025411
- Acronym / sponsor ID
- SI-VIM / 18CH200
- Conditions
- Stroke
- Keywords
- Stroke, Upper limb rehabilitation, Computerized mirror therapy, Hemiparetic, Mirror therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Saint-Etienne Métropole
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 3 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 18 Jul 2019 (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.
Mirror Therapy (TM) has been shown to be effective in motor rehabilitation of the hemiplegic upper limb, but its implementation in current clinical practice has several difficulties, both from the patient and physiotherapist point of view.
A new computerized Mirror Therapy (TM) device (Intensive Visual Simulation 3 (IVS3), Dessintey) which aims to solve the TM compliance problems and make it more efficient have been developed.
Detailed description
The aim of this study is to compare the observance and efficiency of the Intensive Visual Simulation 3 (IVS3) therapy as compared to traditional Mirror Therapy (TM) in a population of hemiplegic stroke patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Intensive Visual Simulation 3 (IVS3) device, Device: Electroencephalography (EEG)Patient with stroke ischemic or hemorrhagic will be included. They will have visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device and electroencephalography (EEG). |
| Control group | Active comparator | Device: traditional Mirror Therapy (TM), Device: Electroencephalography (EEG)Patient with stroke ischemic or hemorrhagic will be included. They will have simulation with the traditional Mirror Therapy (TM) and electroencephalography (EEG). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- First ischemic or hemorrhagic stroke for less than one year
- Not having reoffend
- Responsible for an initially complete hemiplegia,
- Upper-limb deficiency with the modified Frenchay Score below 70,
- Not neurological history other than stroke,
Key exclusion criteria (9 listed)
- Patient who have not Magnetic Resonance Images (MRI) of the brain during stroke
- Having complete lesion of the primary motor cortex
- With an addiction to alcohol or drugs
- With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignancy, severe renal or pulmonary impairment
- History of associated disabling general disease
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 |
|---|---|---|
| Intensive Visual Simulation 3 (IVS3) deviceAlso: Computerized Mirror Therapy (TM) deviceVisual motor simulation with the Intensive Visual Simulation 3 (IVS3) device will be realized and consist of 5 sessions per week for 4 weeks (20 minutes). The patient looks on a screen in front of him, mirroring the movements made by his healthy hand, while attempting to perform the same movement with his paretic hand. | Device | Experimental group |
| traditional Mirror Therapy (TM)Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes). | Device | Control group |
| Electroencephalography (EEG)Electroencephalography (EEG) will be performed during the 1st, 6th, 11th, 16th and 20th session of their programme will be made in order to evaluate brain activity. | Device | Control group, Experimental group |
Primary outcome
Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
Time frame: Day: 0, 18, 32, 60
Measured by Fugl-Meyer motor assessment score at baseline, at 18 days, at 32 days, and at 60 days. Fugl-Meyer score assesses the analytical motor skills of the upper limb with minimum score at 0 (hemiplegia) and maximum score at 66 (normal motor performance).
4 secondary outcomes
Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.
Time frame: Day: 0, 18, 32, 60
Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.
Time frame: Day: 0, 18, 32, 60
Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.
Time frame: Day: 0, 18, 32, 60
Analysis of brain activity
Time frame: Month: 2
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 9 Apr 2024.
- 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.
Pascal GIRAUX, MD PhD 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 Intensive Visual Simulation 3 (IVS3) device, traditional Mirror Therapy (TM) and Electroencephalography (EEG) in people with 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 7 inclusion and 9 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 9 Apr 2024. 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 from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days (time frame: Day: 0, 18, 32, 60). 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 9 Apr 2024.