NCT06230796

Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke

Effects of FES-cycling in Patients With Hemiparesis After Stroke

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: UGECAM Rhône-Alpes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

Detailed description

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

Conditions

• Hemiparesis;Poststroke/CVA

Interventions

Type	Name	Description
DEVICE	FES-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).
DEVICE	SHAM-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. 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).

Timeline

• Start date: 2023-11-17
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2024-01-30
• Last updated: 2025-09-19

Locations

1 site across 1 country: France