Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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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 | DecenTrialz