Rehabilitation program for improving walking after stroke
Awakening of the Control of the Ankle Dorsiflexors in the Post Stroke Hemiplegic Subject to Improve Walking Activity and Social Participation: Experimental Interventional Study
NA · University Hospital, Limoges · NCT04800601
This study is testing a special exercise program to see if it can help stroke patients walk better and get more involved in their daily lives after they leave the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges (other) |
| Locations | 7 sites (Bidart and 6 other locations) |
| Trial ID | NCT04800601 on ClinicalTrials.gov |
What this trial studies
This multi-center, interventional study aims to evaluate a rehabilitation protocol focused on enhancing ankle dorsiflexor muscle strength in stroke patients during the sub-acute phase. Participants will be randomly assigned to either a control group receiving conventional rehabilitation or an experimental group performing intensive ankle exercises using an isokinetic dynamometer five times a week for six weeks. The primary goal is to assess the impact of this program on walking speed and social participation post-discharge. The study involves five centers and aims to recruit a significant number of patients to validate the effectiveness of this approach.
Who should consider this trial
Good fit: Ideal candidates are patients who have experienced their first ischemic or hemorrhagic stroke and are in the sub-acute phase of recovery with persistent foot lift deficiencies.
Not a fit: Patients with severe cognitive disorders, pre-existing gait issues, or significant spasticity may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve walking speed and social participation for stroke survivors.
How similar studies have performed: While similar approaches have been explored, this specific protocol's focus on ankle muscle strength in a large cohort is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First stroke, * Ischemic or hemorrhagic stroke hospitalized in MPR in sub-acute phase (15 days to 3 months) * Persistent deficiency of foot lifts (Medical Research Council testing: MRC \<5) * Walking alone at least 10 meters with or without technical assistance * Absence of pain in the lower limb (EVA \<2) Exclusion Criteria: * Cognitive or phasic disorders that do not make it possible to understand the instructions: Boston Scale BDAE \<2 * Gait disorder before stroke * Fixed stiffness of the ankle (irreducible equine less than 30 °) * Spasticity too important: Modified Ashworth (MAS) greater than or equal to 4. * Pregnancy or desire for pregnancy, breastfeeding * Patient under curatorship or guardianship or under the protection of justice
Where this trial is running
Bidart and 6 other locations
- Reeducation Institute Les Embruns — Bidart, France (TERMINATED)
- University Hospital — Bordeaux, France (ACTIVE_NOT_RECRUITING)
- DUBOIS Hospital — Brive-la-Gaillarde, France (NOT_YET_RECRUITING)
- University Hospital — Limoges, France (RECRUITING)
- University Institute of Rehabilitation Valmante Sud — Marseille, France (RECRUITING)
- Functional rehabilitation center — Noth, France (NOT_YET_RECRUITING)
- University Hospital — Poitiers, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Christophe DAVIET — University Hospital, Limoges
- Study coordinator: Jean-Christophe DAVIET, Pr
- Email: jean-christophe.daviet@unilim.fr
- Phone: + 33 5 55 05 65 38
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: Stroke Rehabilitation