Effects of electrical stimulation cycling for stroke recovery
Effects of FES-cycling in Patients With Hemiparesis After Stroke
NA · UGECAM Rhône-Alpes · NCT06230796
This study tests if using electrical stimulation while cycling can help people with weakness on one side after a stroke improve their heart fitness better than regular cycling.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UGECAM Rhône-Alpes (other) |
| Locations | 1 site (Saint-Didier-au-Mont-d'Or, France) |
| Trial ID | NCT06230796 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of functional electrical stimulation (FES) assisted cycling compared to standard cycling in improving cardiovascular fitness in patients with hemiparesis following a stroke. Participants will be randomly assigned to either the FES cycling group or a placebo group, with both groups engaging in 30 minutes of cycling three times a week for eight weeks. The study will assess participants' fitness levels before and after the intervention, as well as at a three-month follow-up. The trial is conducted in a single-blind manner to minimize bias.
Who should consider this trial
Good fit: Ideal candidates are adults who have experienced a unilateral first-ever stroke and have hemiparesis, with sufficient cognitive function to participate.
Not a fit: Patients with a history of neurological disorders, cardiovascular instability, or those unable to exercise on a cyclo-ergometer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance cardiovascular fitness and overall recovery in stroke patients with hemiparesis.
How similar studies have performed: Other studies have shown promise in using electrical stimulation for rehabilitation, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint-Didier-au-Mont-d'Or, France
- SMR Val Rosay — Saint-Didier-au-Mont-d'Or, France, France (RECRUITING)
Study contacts
- Study coordinator: julie Di marco, MD
- Email: dr.jdimarco@gmail.com
- Phone: 01133472532161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemiparesis, Poststroke/CVA, cycling, exercises, functional electrical stimulation