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

Hemiparesis;Poststroke/CVA Clinical Trial

— AVCyclES  

Official title:

Effects of FES-cycling in Patients With Hemiparesis After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06230796
• Other study ID #: 2023-01-VR
• Secondary ID: 2023-A00627-38
• Status: Recruiting
• Phase: N/A
• Start date: November 17, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: January 2024
• Source: UGECAM Rhône-Alpes
• Contact: julie Di marco, MD
• Phone: 01133472532161
• Email: dr.jdimarco[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemiparesis;Poststroke/CVA
• Paresis

Intervention

Device:
• FES-cycling
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
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).

Locations

Country	Name	City	State
France	SMR Val Rosay	Saint didier au mont d'or

Sponsors (1)

Lead Sponsor	Collaborator
UGECAM Rhône-Alpes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	2 months
Secondary	Walking ability	walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)	4 months
Secondary	quadriceps muscular thickness	quadriceps muscular thickness measured with ultrasound at inclusion aand after the training	2 months
Secondary	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)	2 months
Secondary	Cognitive function	Paper test: Stroop and trail making test at inclusion and after training	2 months