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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A01226-43 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Maison LLAFIA | UNKNOWN |
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Stroke is the leading cause of acquired disability in adults. Stroke causes death in 10% of patients, disability and functional handicap in 60% of cases. Sequelea of hemiplegia include spasticity resulting in great difficulty and slowness in walking, gait instability, increasing the risk of falls.
Deambulation may need help (cane, crutch, tripod cane, walker). Lower limb spasticity includes hypertonia of extensors (gluteus maximus, quadriceps, posterior gastrocnemius) resulting in equinovarus. A neurology deficit may be present on ipsilateral lower limb flexors. Hence the patient walks with rubbing of the tip of the foot (tip-toeing gait), resulting in a "mowing wheatslike" movement of the leg as described in the French literature. Walking is then slowed down, unstable, with increased risk of falls.
In post stroke, during the period of rehabilitation and beyond, it is advisable to wear sports shoes although custom-made shoes improve walking and are reimbursed by the French social security system after prior agreement. Most of patients only wear conventional shoes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REMARCHE® shoes | Experimental | REMARCHE™ shoes are custom-hand-made, with soles adapted to posture, integrated elevator splint, and raise of the tip of the shoes, and contra-lateral leg elevation to avoid friction of the tip of the ipsilateral foot |
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| Sham REMARCHE® shoes | Sham Comparator | Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REMARCHE® shoes | Device | REMARCHE® shoes custom-hand-made, with soles adapted to posture, integrated elevator splint, and raise of the tip of the shoes, and contra-lateral leg elevation to avoid friction of the tip of the ipsilateral foot |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in timed walking performance for 30 steps on the pathological side between D0 and D30. | Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre AMARENCO, Pr | Contact | +33 (0)1 40 25 87 25 | pierre.amarenco@aphp.fr |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| D003025 | Clubfoot |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Sham REMARCHE® shoes | Device | Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D005532 | Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |