Clinical trial NCT04025411: Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.
Official title: Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Upper limb rehabilitation
Computerized mirror therapy
Hemiparetic
Mirror therapy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Saint-Etienne Métropole
First posted: 2019-07-18
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
timeFrame: Day: 0, 18, 32, 60
Secondary outcomes:
measure: Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.
timeFrame: Day: 0, 18, 32, 60
measure: Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.
timeFrame: Day: 0, 18, 32, 60
measure: Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.
timeFrame: Day: 0, 18, 32, 60
measure: Analysis of brain activity
timeFrame: Month: 2
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Pascal GIRAUX, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: