Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Change from baseline Fugl-Meyer motor assessment score at 18 days, at 32 days, and at 60 days
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change from baseline Barthel index at 18 days, at 32 days, and at 60 days.(Day: 0, 18, 32, 60)
- Change from baseline Abilhand questionnaire at 18 days, at 32 days, and at 60 days.(Day: 0, 18, 32, 60)
- Change from baseline modified Frenchay Arm Test score at 18 days, at 32 days, and at 60 days.(Day: 0, 18, 32, 60)
- Analysis of brain activity(Month: 2)