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

NCT06230796 | Recruiting

• 2 other identifiers: 2023-01-VR2023-A00627-38
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Hemiparesis;Poststroke/CVA

Keywords

cycling; exercises; functional electrical stimulation

Outcome Measures

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).

  From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (5)

• Maximum power

  2 months

• Walking ability

  4 months

• quadriceps muscular thickness

  2 months

• Middle Cerebral Artery Blood Flow Velocity During Exercise

  2 months

• Cognitive function

  2 months

Study Arms (2)

FES-cycling

EXPERIMENTAL

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

Device: FES-cycling

SHAM-cycling

SHAM COMPARATOR

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

Device: SHAM-cycling

Interventions

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).

FES-cycling

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).

SHAM-cycling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UGECAM Rhône-Alpes: lead

Study Sites (1)

SMR Val Rosay

Saint-Didier-au-Mont-d'Or, France, 69370, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

julie Di marco, MD

CONTACT

01133472532161; dr.jdimarco@gmail.com

Sarah Finel

CONTACT

secmedhdj.valrosay@ugecam.assurance-maladie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Sham stimulation
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: November 17, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (1)