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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01883-52 | Other Identifier | ANSM |
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The study was stopped due to lack of inclusions
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with first ischemic or hemorrhagic stroke | Experimental | Patient with first ischemic or hemorrhagic stroke will be included. They will have the following program Computerized Mirror Therapy (CMT) associated at transcranial Direct Current Stimulation (tDCS). This program will consist of 5 sessions per week for 4 weeks (20 minutes). In more, they will have the following tests: Tolerance Assessment Questionnaire, Ashworth's scale, Frenchay arm test, Abilhand questionnaire, Fugl-Meyer test, and Goal Attainment Scaling (GAS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial Direct Current Stimulation (tDCS) | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of observance of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) | Rate of observance of the program CMT + tDCS. It is will be measured by the number of patients who will be finished the study. | Up to Day 40 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test | 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. | Day 40 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascal GIRAUX, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint-Etienne | Saint-Etienne | France |
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| Computerized Mirror Therapy (CMT) | Diagnostic Test | 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). |
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| Tolerance Assessment Questionnaire | Diagnostic Test | The Tolerance Assessment Questionnaire will be completed at the end of each session. |
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| Ashworth's scale | Diagnostic Test | 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. |
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| Frenchay arm test | Diagnostic 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. |
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| Abilhand questionnaire | Diagnostic Test | 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. |
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| Fugl-Meyer test | Diagnostic 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. |
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| Goal Attainment Scaling (GAS) | Diagnostic Test | 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. |
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| Effect of the program Computerized Mirror Therapy (CMT) + transcranial Direct Current Stimulation (tDCS) improving activities of the upper limb - measured by Frenchay arm test | 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. | Day 70 |
| occurrence of epileptic seizure | 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. | Day 40 |
| occurrence of Anxiety crisis | 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. | Day 40 |
| Tolerance Assessment Questionnaire | Analysis the results of the Tolerance Assessment Questionnaire. | Up to day 70 |
| Evaluation of the program by Goal Attainment Scaling (GAS) | Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results. | Day 40 |
| Evaluation of the program by Goal Attainment Scaling (GAS) | Analysis of evaluation of the program by Goal Attainment Scaling (GAS) results. | Day 70 |
| Quantitative improvement of the deficiencies - Fugl-Meyer test | Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results. | Day 40 |
| Quantitative improvement of the deficiencies - Fugl-Meyer test | Measure of the quantitative improvement of the deficiencies by analysis of Fugl-Meyer test results. | Day 70 |
| Abilities to perform several activities - Abilhand questionnaire | Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results. | Day 40 |
| Abilities to perform several activities - Abilhand questionnaire | Analysis of abilities to perform several activities in the daily life by Abilhand questionnaire results. | Day 70 |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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