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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A03467-32 | Other Identifier | ID-RCB |
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The study is a comparative study, to show that the administration of RSS stimulation on the face compared to the administration of strategy Sham stimulation, results in an temporary improvement in the tactile acuity of the hand in patients with tactile acuity impairment of the hand due to stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSS | Experimental | Repetitive somatosensory stimulation (RSS) |
|
| Sham RSS | Placebo Comparator | Sham Repetitive somatosensory stimulation (RSS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RSS | Procedure | Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS |
| Measure | Description | Time Frame |
|---|---|---|
| Tactile acuity : 2 point discrimination test | The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS. Spatial discrimination of the finger, Absolute threshold detection of the finger. | Week 3 |
| Tactile acuity : Absolute threshold detection test after 3h of RSS | The Primary outcome measure is a composite of 2point discrimination test (2PDT) and Absolute threshold detection test after 3h of RSS. Spatial discrimination of the finger, Absolute threshold detection of the finger. | Week 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Jebsen-Taylor hand function test (JTHFT) | Overall functionality of the hand, especially with regard to handling objects | Week 3 |
| Questionnaire comfort/ease to use | A self-reported assessment will be administered after the completion of testing procedure: a custom-made questionnaire including the ease of use, perceived sensations during RSS, easy positioning, pain on removal, positive and negative aspects of RSS, willing to continue using after release from the hospital, and willing to recommend to others. |
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Inclusion Criteria:
Non-Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques LUAUTE, PU-PH | Contact | 4 78 86 50 23 | +33 | jacques.luaute@chu-lyon.fr |
| Gilles RODE, PU-PH | Contact | 4 78 86 50 66 | +33 | gilles.rode@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jacques LUAUTE, PU-PH | Service de Médecine Physique et Réadaptation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupement Hospitalier du Sud - Hôpital Henry Gabrielle | Saint-Genis-Laval | 69230 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D019066 | Facies |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Double Blind
|
| Week 3 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |