Effects of Functional Electrical Stimulation Assisted Cycling in Patients With Hemiparesis After Stroke (AVCyclES)

UGECAM Rhône-Alpes

Status: Enrolling

Conditions: Hemiparesis;Poststroke/CVA

Treatments: Device: SHAM-cycling; Device: FES-cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT06230796

2023-01-VR

2023-A00627-38 (Other Identifier)

Details and patient eligibility

About

To determine whether active cycling assisted by functional electrical stimulation (FES) Is more effective than active cycling on cardiovascular fitness in post stroke hemiparesis

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

FES-cycling

Experimental group

Description:

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

Treatment:

Device: FES-cycling

SHAM-cycling

Sham Comparator group

Description:

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

Treatment:

Device: SHAM-cycling