Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230796
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-19
Brief Title:
Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke
Sponsor:
UGECAM Rhône-Alpes
Organization:
UGECAM Rhône-Alpes
Study Overview
Official Title:
Effects of FES-cycling in Patients With Hemiparesis After Stroke
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AVCyclES
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 timesweeks 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
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 timesweeks 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00627-38 | OTHER | ID-RCB | None |