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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
OTHER	Adapted physical activity program	Rehabilitation
OTHER	Adapted physical activity self-program	Rehabilitation

Timeline

• Start date: 2024-09-27
• Primary completion: 2026-12-26
• Completion: 2027-03-26
• First posted: 2023-09-29
• Last updated: 2026-02-05

Locations

1 site across 1 country: France