Hemiparesis;Poststroke/CVAAVCyclESNCT06230796
Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke
A study testing FES-cycling in people with Hemiparesis;Poststroke/CVA, run by UGECAM Rhône-Alpes at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- FES-cycling
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Finel contact
France1 site, 1 recruiting
- Recruiting
SMR Val Rosay
Saint-Didier-au-Mont-d'Or, France, 69370
julie di marco, MD, 01133472532161, dr.jdimarco@gmail.com
julie di marco, MD
About this study
Official title: 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
Read the 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
- Being tested
- FES-cycling, SHAM-cycling
- Keywords
- cycling, exercises, functional electrical stimulation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FES-cyclingDevice
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-cyclingDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: FES-cycling |
| 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 Receives: Device: SHAM-cycling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 8 weeks
Secondary outcomes (5)
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)
Measured: 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)
Measured: 4 months
quadriceps muscular thickness
quadriceps muscular thickness measured with ultrasound at inclusion aand after the training
Measured: 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)
Measured: 2 months
Cognitive function
Paper test: Stroop and trail making test at inclusion and after training
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start17 Nov 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis;Poststroke/CVAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UGECAM Rhône-Alpes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230796
- Sponsor's protocol ID
- 2023-01-VR
- Other IDs
- 2023-A00627-38
- Acronym
- AVCyclES
- Status last verified
- Sep 2025
- First submitted
- 19 Jan 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of FES-cycling in Patients With Hemiparesis After Stroke
- ClinicalTrials.gov ID
- NCT06230796
- Acronym / sponsor ID
- AVCyclES / 2023-01-VR
- Conditions
- Hemiparesis;Poststroke/CVA
- Keywords
- cycling, exercises, functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- UGECAM Rhône-AlpesUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FES-cycling | Experimental | Device: FES-cycling30 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 | Device: SHAM-cycling30 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FES-cycling30 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 | FES-cycling |
| SHAM-cycling30 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). | Device | SHAM-cycling |
Primary outcome
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).
5 secondary outcomes
Maximum power
Time frame: 2 months
Walking ability
Time frame: 4 months
quadriceps muscular thickness
Time frame: 2 months
Middle Cerebral Artery Blood Flow Velocity During Exercise
Time frame: 2 months
Cognitive function
Time frame: 2 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Finel contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FES-cycling in people with Hemiparesis;Poststroke/CVA, run by UGECAM Rhône-Alpes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact julie Di marco, MD (01133472532161, dr.jdimarco@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 peak at 2 months (L/min) (time frame: From enrollment to the end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.