Effects of FES-cycling in Patients With Hemiparesis After Stroke
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hemiparesis;Poststroke/CVA
- Sponsor
- UGECAM Rhône-Alpes
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- VO2 peak at 2 months (L/min)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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
Investigators
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
Outcomes
Primary Outcomes
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
- Cognitive function(2 months)
- Maximum power(2 months)
- Walking ability(4 months)
- quadriceps muscular thickness(2 months)
- Middle Cerebral Artery Blood Flow Velocity During Exercise(2 months)