NCT06061770 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
| NCT ID | NCT06061770 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique Hopitaux De Marseille |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2026-12-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-09-27 with a primary completion date of 2026-12-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06061770 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06061770 currently recruiting?
Yes, NCT06061770 is actively recruiting participants. Contact the research team at maeva.cotinat@ap-hm.fr for enrollment information.
Where is the NCT06061770 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT06061770 clinical trial?
NCT06061770 is sponsored by Assistance Publique Hopitaux De Marseille. The trial plans to enroll 40 participants.
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