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 (StrokAPA)

February 3, 2026 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bouches du Rhône
      • Marseille, Bouches du Rhône, France, 13009
        • Recruiting
        • Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First APA program

The evaluation of the primary endpoint to meet our main objective will be done at W13 for both groups. The addition of an APA program in autonomy following the structured program for group 1 will make it possible to answer a secondary question focusing on the comparison of the effectiveness of the self-directed program carried out alone or following a structured program.

1st group: D0: Include S1-S12: APA program at IUR Valmante S13: Break S14-S25: APA Autoprogram

In addition, the patients in group 1 are maintained in the follow-up to study the maintenance of any observed effect.
Other: Adapted physical activity program
Rehabilitation
Active Comparator: Second APA program

Our study design provides for compensatory participation in the structured program for patients in group 2, following the self-program. From an ethical point of view, this scheme allows all patients included in the structured APA program to benefit.

2nd group: D0: Include S1-S12: APA Autoprogram S13: End of study S14-S25: APA program at IUR Valmante compensatory
Other: Adapted physical activity self-program
Rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily activity measurement
Time Frame: through study completion
Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device
through study completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate physical activities in Written report
Time Frame: through study completion
carried out by the patient, more or less helped by his close entourage, recorded in a notebook given at the beginning of the study
through study completion
6-minute walk test (6MWT)
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
A test validated in the literature that consists of measuring the greatest distance that a subject can travel on a flat surface (30 meter corridor) in 6 minutes.
at inclusion Day and at the 13th week (and the 26th week for one group only)
Measurement of heart rate at rest and after 6-minute walk test
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
with a blood pressure cuff
at inclusion Day and at the 13th week (and the 26th week for one group only)
Measurement of systolic blood pressure at rest and after 6-minute walk test
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
with a blood pressure cuff
at inclusion Day and at the 13th week (and the 26th week for one group only)
Borg Rating Scale of Exertion
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
test validated in the literature that allows the evaluation of the perception of effort by the patient ; minimum value : 0 = rest : no exertion ; maximum value : 10 = maximal exertion
at inclusion Day and at the 13th week (and the 26th week for one group only)
Stroke Specific Quality of Life scale (SS-QoL)
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
A test validated in French in the literature that assesses the specific quality of life of stroke patients in 49 items ; minimum value : 1 = Total help/ Couldn't do it at all/ Strongly agree ; maximum value : 5 = No help needed/ No trouble at all/ Strongly disagree
at inclusion Day and at the 13th week (and the 26th week for one group only)
Berg Balance Scale (BBS)
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
validated scale allowing, by means of 14 instructions, an evaluation of balance, reproducible and sensitive to change ; minimum score : 0-20 = high risk of falling ; maximal score : 56 = no risk of falling
at inclusion Day and at the 13th week (and the 26th week for one group only)
Activity-specific Balanced Confidence scale (ABC scale)
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
French language validated scale assessing the patient's confidence in his or her balance, using 16 situations where the subject is asked to rate his or her balance on a numerical scale ; minimal rate : 0% = not at all confident ; maximal rate : 100% = completely confident
at inclusion Day and at the 13th week (and the 26th week for one group only)
Behavioral regulation in exercise questionnaire
Time Frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
scale used in the literature to assess motivation to perform physical activity ; minimal value : 1 = not true at all ; maximal value : 7 = absolutely true
at inclusion Day and at the 13th week (and the 26th week for one group only)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2024

Primary Completion (Estimated)

December 26, 2026

Study Completion (Estimated)

March 26, 2027

Study Registration Dates

First Submitted

September 18, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCAPHM21_0439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data sharing statements that meet these ICMJE requirements Individual pseudonymous data of participants may be available The data that may be shared are the individual data of the participants which underlie the results reported in this article, after de-identification (text, tables, figures and appendices).

IPD Sharing Time Frame

Beginning 3 months and ending 3 years following article publication.

IPD Sharing Access Criteria

For researchers who provide a methodologically sound proposal. Types of analyses: Achieve the objectives of the approved proposal. Proposals should be sent to maeva.cotinat@ap-hm.fr

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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