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

Not Applicable

Recruiting

• Conditions: Hemiparesis;Poststroke/CVA
• Interventions: Device: SHAM-cycling; Device: FES-cycling

• Registration Number: NCT06230796
• Lead Sponsor: UGECAM Rhône-Alpes

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

Detailed 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

Study Timeline

• Study Start: 2023-11-17
• Status Verified: 2024-01
• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Last Update Submitted: 2024-01-19
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHAM-cycling	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
FES-cycling	FES-cycling	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

Primary Outcome Measures

Name	Time	Method
VO2 peak at 2 months (L/min)	From enrollment to the end of treatment at 8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Maximum power	2 months	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)
Walking ability	4 months	walking speed (10m walking test) and distance (6-minute walking test) measured at inclusion, after training (M2) ans follow-up (M4)
quadriceps muscular thickness	2 months	quadriceps muscular thickness measured with ultrasound at inclusion aand after the training
Middle Cerebral Artery Blood Flow Velocity During Exercise	2 months	Middle Cerebral Artery Blood Flow Velocity During Exercise measured with transcranial Doppler ultrasound at inclusion (M0) and after the training (M2)
Cognitive function	2 months	Paper test: Stroop and trail making test at inclusion and after training

Trial Locations

Locations (1)

SMR Val Rosay; 🇫🇷 Saint didier au mont d'or, France