Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients.

Stroke Clinical Trial

— SI-VIM  

Official title:

Effectiveness of Computerized Device New of Visual Motor Simulation Versus Mirror Therapy in Hemiplegic Patients. SI-VIM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04025411
• Other study ID #: 18CH200
• Secondary ID: 2019-A00041-56
• Status: Completed
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: July 6, 2023

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: July 6, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Intensive Visual Simulation 3 (IVS3) 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)
Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
• 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.

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Saint-Etienne Métropole

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Day: 0, 18, 32, 60
Secondary	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).	Day: 0, 18, 32, 60
Secondary	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).	Day: 0, 18, 32, 60
Secondary	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).	Day: 0, 18, 32, 60
Secondary	Analysis of brain activity	Measured by Electroencephalography (EEG) results.	Month: 2