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

Effects of FES-cycling in Patients With Hemiparesis After Stroke

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

Study Overview

• Status: Recruiting
• Conditions: Hemiparesis;Poststroke/CVA
• Intervention / Treatment: Device: FES-cycling; Device: SHAM-cycling

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

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: julie di marco, MD; Phone Number: 01133472532161; Email: dr.jdimarco@gmail.com
• Study Contact Backup: Name: Sarah Finel; Email: secmedhdj.valrosay@ugecam.assurance-maladie.fr

Study Locations

• France
  • France
    • Saint-Didier-au-Mont-d'Or, France, France, 69370
      • Recruiting
      • SMR Val Rosay
      • Principal Investigator: Julie DI MARCO, MD
      • Contact: julie di marco, MD; Phone Number: 01133472532161; Email: dr.jdimarco@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults with Hemiparesis after an unilateral first ever stroke
• Able to walk in security
• Time since stroke within 3 months to 1 year
• Sufficient cognitive function to understand and perform corresponding tasks

Exclusion Criteria:

• Any history of neurological disorders or cardiovascular instability
• High spasticity on ankle, knee, hip muscles
• Inability to exercise on a cyclo-ergometer
• Pacemaker and other contraindications of the use of electrical stimulation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FES-cycling; 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 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).
Sham Comparator: 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	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: UGECAM Rhône-Alpes

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: functional electrical stimulation; cycling; exercises
• Additional Relevant MeSH Terms: Behavior; Motor Activity
• Other Study ID Numbers: 2023-01-VR; 2023-A00627-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No