Comparing two physical activity programs for stroke recovery
Comparison of the Effectiveness of an Adapted Physical Activity Program in a Dedicated Structure to a Self-program in Patients in Chronic Phase of a Stroke
NA · Assistance Publique Hopitaux De Marseille · NCT06061770
This study tests which physical activity program works better for people recovering from a stroke: one led by trainers in a facility or one they do on their own.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille (other) |
| Locations | 1 site (Marseille, Bouches du Rhône) |
| Trial ID | NCT06061770 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to compare the effectiveness of an adapted physical activity program conducted in a dedicated structure against a self-directed physical activity program for patients in the chronic phase of stroke recovery. Participants will be randomized into two groups, with both receiving physical activity interventions. The primary outcome will be measured by the number of steps taken daily, tracked using a Stepwatch™ device over the study duration. The study focuses on patients with spastic hemiparesis following a unilateral stroke, ensuring they can walk for at least six minutes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with spastic hemiparesis from a first unilateral stroke occurring more than six months prior, who can walk for six minutes.
Not a fit: Patients who are unable to walk without assistance or have significant cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance rehabilitation strategies for stroke patients, potentially improving their mobility and quality of life.
How similar studies have performed: While this approach is not widely tested, similar studies have shown promise in enhancing physical activity outcomes in stroke rehabilitation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than 18 years * Left or right spastic hemiparesis after a first hemorrhagic or ischemic unilateral stroke older than 6 months * Walking possible for 6 minutes Exclusion Criteria: * Inability to walk without human assistance (with or without technical aids) * Cognitive impairment that compromises informed consent, including inability to understand the purpose and terms of the protocol * Inability to communicate * Presence of an additional neurological disorder * Medical conditions that contraindicate physical activity, such as an unbalanced cardiovascular or respiratory condition * Concurrent participation in another clinical research project
Where this trial is running
Marseille, Bouches du Rhône
- Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite — Marseille, Bouches du Rhône, France (RECRUITING)
Study contacts
- Study coordinator: Maeva COTINAT
- Email: maeva.cotinat@ap-hm.fr
- Phone: 04 91 74 42 00
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