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

ConditionHemiparesis;Poststroke/CVA
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUGECAM Rhône-Alpes

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • FES-cycling

    Device

    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).

  • SHAM-cycling

    Device

    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).

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: FES-cyclingExperimental treatment 1 intervention
Group B: SHAM-cyclingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

VO2 peak at 2 months (L/min)

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).

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

Maximum power

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)

Time frame
2 months
2

Walking ability

walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)

Time frame
4 months
3

quadriceps muscular thickness

quadriceps muscular thickness measured with ultrasound at inclusion aand after the training

Time frame
2 months
4

Middle Cerebral Artery Blood Flow Velocity During Exercise

Middle Cerebral Artery Blood Flow Velocity During Exercise measured with transcranial Doppler ultrasound at inclusion (M0) and after the training (M2)

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UGECAM Rhône-Alpes

Lead sponsor

Source ClinicalTrials.gov
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