Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06230796

Effects of Functional Electrical Stimulation Assisted 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Hemiparesis;Poststroke/CVA Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SMR Val Rosay

Saint-Didier-au-Mont-d'Or, France, 69370

Location status: Recruiting

Location contact

julie di marco, MD

CONTACT

[email protected]

01133472532161

julie di marco, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

Primary outcomes

  1. VO2 peak at 2 months (L/min)

    Time frame: From enrollment to the end of treatment at 8 weeks

    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).

Secondary outcomes

  1. Maximum power

    Time frame: 2 months

    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. Walking ability

    Time frame: 4 months

    walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)

  3. quadriceps muscular thickness

    Time frame: 2 months

    quadriceps muscular thickness measured with ultrasound at inclusion aand after the training

  4. Middle Cerebral Artery Blood Flow Velocity During Exercise

    Time frame: 2 months

    Middle Cerebral Artery Blood Flow Velocity During Exercise measured with transcranial Doppler ultrasound at inclusion (M0) and after the training (M2)

  5. Cognitive function

    Time frame: 2 months

    Paper test: Stroop and trail making test at inclusion and after training

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Finel

CONTACT

[email protected]

julie Di marco, MD

CONTACT

[email protected]

01133472532161

Sponsors and collaborators

Lead sponsor

UGECAM Rhône-Alpes

Other

Registry information

Official study title

Effects of FES-cycling in Patients With Hemiparesis After Stroke

Acronym: AVCyclES

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2024
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.