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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00627-38 | Other Identifier | ID-RCB |
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To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis
Design: In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.
Setting: Neurologic Rehabilitation Unit Interventions: 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8).
In addition to the assigned group treatment, subjects will perform their own standard rehabilitation program.
Participants will be evaluated before training, after training, and at 3 month follow-up visit
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FES-cycling | Experimental | 30 minutes of active leg cycling with FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks |
|
| SHAM-cycling | Sham Comparator | 30 minutes of active leg cycling with Sham FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES-cycling | Device | 30 minutes of active leg cycling with or without FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8). |
| Measure | Description | Time Frame |
|---|---|---|
| VO2 peak at 2 months (L/min) | Comparison of the maximum oxygen consumption (VO2 peak in L/min) measured during an incremental maximum stress test on cyclo-ergometer between the end of training (M2) and inclusion (M0). | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum power | Comparison of the maximum power (in Watts) developed during the stress test on a cycloergometer between the end of the training (M2) and the inclusion (M0) | 2 months |
| Walking ability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| julie Di marco, MD | Contact | 01133472532161 | dr.jdimarco@gmail.com | |
| Sarah Finel | Contact | secmedhdj.valrosay@ugecam.assurance-maladie.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMR Val Rosay | Recruiting | Saint-Didier-au-Mont-d'Or | France | 69370 | France |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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In a monocentric, single-blind, randomized, controlled trial, hemiparetic post stroke patients will be randomized to receive FES-induced cycling training or placebo FES cycling.
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Sham stimulation
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| SHAM-cycling | Device | 30 minutes of active leg cycling with SHAM FES applied to the paretic rectus femoris of quadriceps and to the biceps femoris and semitendinosus muscles and gluteus maximus, 3 times/weeks for 8 weeks. During training, participants will be seated on a FES-Cycle (Hepha Bike, Kurage): a cyclo-ergometer (Technogym) combined with a 8 channel controlled stimulator (Motimove-8). |
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walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)
| 4 months |
| quadriceps muscular thickness | quadriceps muscular thickness measured with ultrasound at inclusion aand after the training | 2 months |
| Middle Cerebral Artery Blood Flow Velocity During Exercise | Middle Cerebral Artery Blood Flow Velocity During Exercise measured with transcranial Doppler ultrasound at inclusion (M0) and after the training (M2) | 2 months |
| Cognitive function | Paper test: Stroop and trail making test at inclusion and after training | 2 months |