Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemi… (NCT04025411) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.
France37 participantsStarted 2019-10-28
Plain-language 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.
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* With clinical involvement of the brainstem
* Pregnancy in progress
* Patients under the protection of justice.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
Timeframe: Day: 0, 18, 32, 60
Trial details
NCT IDNCT04025411
SponsorCentre Hospitalier Universitaire de Saint Etienne