Stroke
Conditions
Keywords
transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT), hemiparetic, Ischemic, stroke, Intensive Visual Simulation3 (IVS3)
Brief summary
Although the mirror therapy is recognized as effective, its practice is difficult, especially with hemiplegic patients. It is difficult for them to understand, control the movements and carry out a double task with the two upper limbs. The implementation of a Computerized Mirror Therapy (CMT) with the Intensive Visual Simulation 3 (IVS3) device makes it possible to limit these problems by proposing pre-recorded sessions, not limited to the right or left hemi-space, and proposing a work on proximal motricity. Since the functional prognosis of the upper hemiplegic limb remains mostly unfavourable, a wide range of interventions should be proposed. There is currently a consensus to consider the use of transcranial Direct Current Stimulation (tDCS) stimulation in functional recovery after stroke as a method to enhance the effectiveness of training techniques. Although all motor therapies can theoretically benefit from increased effectiveness by the addition of transcranial Direct Current Stimulation (tDCS), Computerized Mirror Therapy (CMT) has a high potential for sensitivity to transcranial Direct Current Stimulation (tDCS) due to the intensity of the motor training of the upper limb applied.
Detailed description
The primary objective of this study is to investigate the feasibility of a program combining Computerized Mirror Therapy (CMT) with dual- transcranial Direct Current Stimulation (tDCS) stimulation by evaluating observance to hemiparetic stroke patients.
Interventions
DIAGNOSTIC_TESTtranscranial Direct Current Stimulation (tDCS)
transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current. Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT).
DIAGNOSTIC_TESTComputerized Mirror Therapy (CMT)
Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).
DIAGNOSTIC_TESTTolerance Assessment Questionnaire
The Tolerance Assessment Questionnaire will be completed at the end of each session.
DIAGNOSTIC_TESTAshworth's scale
Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.
DIAGNOSTIC_TESTFrenchay arm test
Frenchay arm test evaluates your abilities with the affected hand to perform several actions. This test will be completed before the start of the program, at the end of the program and one month after.
DIAGNOSTIC_TESTAbilhand questionnaire
Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected. This test will be completed before the start of the program, at the end of the program and one month after.
DIAGNOSTIC_TESTFugl-Meyer test
Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected. This test will be completed before the start of the program, at the end of the program and one month after.
DIAGNOSTIC_TESTGoal Attainment Scaling (GAS)
Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program. These goals will be checked at the end of the program and one month after.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patient with first ischemic or hemorrhagic stroke for less than one year, having not recidivated since then and responsible for initially complete left or right hemiplegia * Modified Frenchay arm test score \<70 (/ 100) * Without a neurological history other than stroke * Having signed the written consent and affiliated or entitled to a social security scheme
Exclusion criteria
* Patient with contraindications to transcranial Direct Current Stimulation (tDCS) or Transcranial Magnetic Stimulation (TMS) (brain metal implant, pacemaker, other implanted active medical device) * Patient who didn't have cerebral Magnetic Resonance Imaging (MRI) imaging during their stroke * With complete lesion of the primary motor cortex * With alcohol / drug dependence * With psychiatric illness, cognitive impairment, uncontrolled disease / epilepsy, malignant disease, severe renal or pulmonary disease * With a history of disabling associated disease * With cerebellar syndrome * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) | Up to Day 40 | Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative improvement of the deficiencies - Fugl-Meyer test | Day 40 | Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results. |
| Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test | Day 40 | To evaluate the effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb. It is will be measured by Frenchay arm test. |
| occurrence of epileptic seizure | Day 40 | Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of epileptic seizure report by adverse event and serious adverse events. |
| occurrence of Anxiety crisis | Day 40 | Measure of tolerance of the program Intensive Visual Simulation 3 (IVS3) + transcranial Direct Current Stimulation (tDCS) by the occurrence of anxiety crisis report by adverse event and serious adverse events. |
| Tolerance Assessment Questionnaire | Up to day 70 | Analysis the results of the Tolerance Assessment Questionnaire. |
| Evaluation of the program by Goal Attainment Scaling (GAS) | Day 40 | Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results. |
| Abilities to perform several activities - Abilhand questionnaire | Day 40 | Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results. |
Countries
France
Outcome results
None listed