An interventional study of FES-cycling and SHAM-cycling in Hemiparesis;Poststroke/CVA, sponsored by UGECAM Rhône-Alpes. Recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by UGECAM Rhône-Alpes · Not applicable, Interventional, and Prevention
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
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →UGECAM Rhône-Alpes is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: FES-cycling
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
Device: SHAM-cycling
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).
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).
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).
Time frame: From enrollment to the end of treatment at 8 weeks
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)
Time frame: 2 months
Walking ability
walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)
Time frame: 4 months
quadriceps muscular thickness
quadriceps muscular thickness measured with ultrasound at inclusion aand after the training
Time frame: 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)
Time frame: 2 months
Cognitive function
Paper test: Stroop and trail making test at inclusion and after training
Time frame: 2 months
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UGECAM Rhône-Alpes