Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FES-cycling, SHAM-cycling.
- Who it may be relevant to
- Registry conditions: Hemiparesis;Poststroke/CVA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of FES-cycling in Patients With Hemiparesis After Stroke
Overview
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
Interventions
- 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).
Primary outcome measures
- VO2 peak at 2 months (L/min) [Time frame: From enrollment to the end of treatment at 8 weeks]
Secondary outcome measures (5)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
France · 1 center
- SMR Val Rosay — Saint-Didier-au-Mont-d'Or
Identifiers
NCT: NCT06230796 · 2023-01-VR · 2023-A00627-38