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NCT06061770Recruiting

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

Source: ClinicalTrials.gov · Last updated 5 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
18 Sept 2023
Start date
27 Sept 2024
Primary completion date
26 Dec 2026
Lead sponsor
Assistance Publique Hopitaux De Marseille
Diseases
Stroke
NCT number
NCT06061770

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 27 Sept 2024 to the primary completion date, 26 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent participation in another clinical research project

Other illness

  • Cognitive impairment that compromises informed consent, including inability to understand the purpose and terms of the protocol
  • Presence of an additional neurological disorder
  • Medical conditions that contraindicate physical activity, such as an unbalanced cardiovascular or respiratory condition

Other

  • Inability to walk without human assistance (with or without technical aids)
  • Inability to communicate

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.