Actively Recruiting
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
Led by Assistance Publique Hopitaux De Marseille · Updated on 2026-02-05
40
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, randomized, controlled, two parallel arms, single-blind pilot study. In this design, all included patients in the chronic phase of a stroke will receive both modes of physical activity. This study includes patients over 18 years of age with spastic hemiparesis sequelae of a first unilateral hemispheric stroke older than 6 months and able to walk for 6 minutes. The non-inclusion criteria were the inability to walk without human assistance (with or without technical aids), the existence of cognitive disorders compromising informed consent, in particular the inability to understand the objective and the modalities of the protocol, the inability to communicate with the examiners, and the presence of an additional neurological disorder or a pathology contraindicating the practice of physical activity. The primary endpoint is based on daily activity measurement by measuring the number of steps per day, collected over the duration of the study, via a Stepwatch™ device. Secondary end points involve a written physical activity report, assessment of walking ability (via walking-test 6, heart rate, and blood pressure), a measure of perceived exertion, stroke-specific quality of life, balance, and motivation to perform physical activity.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 18 years
- Left or right spastic hemiparesis after a first hemorrhagic or ischemic unilateral stroke older than 6 months
- Able to walk for 6 minutes
You will not qualify if you...
- Inability to walk without human assistance (with or without technical aids)
- Cognitive impairment compromising informed consent, including inability to understand study purpose and procedures
- Inability to communicate with examiners
- Presence of an additional neurological disorder
- Medical conditions contraindicating physical activity, such as unstable cardiovascular or respiratory issues
- Participation in another clinical research project
AI-Screening
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Trial Site Locations
Total: 1 location
1
Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite
Marseille, Bouches du Rhône, France, 13009
Actively Recruiting
Research Team
M
Maeva COTINAT
CONTACT
C
Claire MORANDO
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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