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

U

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

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

Trial contacts and locations

1

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Central trial contact

Sarah Finel; julie Di marco, MD

Data sourced from clinicaltrials.gov

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