Hemiparesis;Poststroke/CVA
Conditions
Keywords
cycling, exercises, functional electrical stimulation
Brief 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
Interventions
DEVICEFES-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).
DEVICESHAM-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).
Sponsors
UGECAM Rhône-Alpes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Sham stimulation
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VO2 peak at 2 months (L/min) | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum power | 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) |
| Walking ability | 4 months | walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4) |
| quadriceps muscular thickness | 2 months | quadriceps muscular thickness measured with ultrasound at inclusion aand after the training |
| Middle Cerebral Artery Blood Flow Velocity During Exercise | 2 months | Middle Cerebral Artery Blood Flow Velocity During Exercise measured with transcranial Doppler ultrasound at inclusion (M0) and after the training (M2) |
| Cognitive function | 2 months | Paper test: Stroop and trail making test at inclusion and after training |
Countries
France
Contacts
Primary Contactjulie Di marco, MD
Backup ContactSarah Finel
Outcome results
None listed