StrokeStrokAPANCT06061770
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
A study testing Adapted physical activity program and Adapted physical activity self-program in people with Stroke, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Adapted physical activity program and Adapted physical activity self-program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2024to 26 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Médecine Physique et de Réadaptation, CHU Hôpital Sainte Marguerite
Marseille, Bouches du Rhône, 13009
About this study
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
- Being tested
- Adapted physical activity program, Adapted physical activity self-program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted physical activity programOther
Rehabilitation
Adapted physical activity self-programOther
Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| First APA program | Experimental | 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. Receives: Other: Adapted physical activity program |
| Second APA program | Active comparator | 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 Receives: Other: Adapted physical activity self-program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily activity measurement
Measuring the number of steps per day, collected over the duration of the study, via a Stepwatch device
Measured: through study completion
Secondary outcomes (9)
the rate physical activities in Written report
carried out by the patient, more or less helped by his close entourage, recorded in a notebook given at the beginning of the study
Measured: through study completion
6-minute walk test (6MWT)
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.
Measured: 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
with a blood pressure cuff
Measured: 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
with a blood pressure cuff
Measured: at inclusion Day and at the 13th week (and the 26th week for one group only)
Borg Rating Scale of Exertion
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
Measured: at inclusion Day and at the 13th week (and the 26th week for one group only)
Stroke Specific Quality of Life scale (SS-QoL)
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
Measured: at inclusion Day and at the 13th week (and the 26th week for one group only)
Berg Balance Scale (BBS)
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
Measured: at inclusion Day and at the 13th week (and the 26th week for one group only)
Activity-specific Balanced Confidence scale (ABC scale)
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
Measured: at inclusion Day and at the 13th week (and the 26th week for one group only)
Behavioral regulation in exercise questionnaire
scale used in the literature to assess motivation to perform physical activity ; minimal value : 1 = not true at all ; maximal value : 7 = absolutely true
Measured: at inclusion Day and at the 13th week (and the 26th week for one group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start27 Sep 2024
- Primary completion26 Dec 2026 (estimated)
- Study completion26 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061770
- Sponsor's protocol ID
- RCAPHM21_0439
- Acronym
- StrokAPA
- Status last verified
- Feb 2026
- First submitted
- 18 Sep 2023
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Satger E, Prieur-Blanc N, Viton JM, Auquier P, Bensoussan L, Cotinat M. Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study. BMJ Open. 2024 Jul 20;14(7):e084688. doi: 10.1136/bmjopen-2024-084688.
PubMed 39032927
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06061770
- Acronym / sponsor ID
- StrokAPA / RCAPHM21_0439
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 26 Dec 2026 (estimated)
- Study completion
- 26 Mar 2027 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First APA program | Experimental | Other: Adapted physical activity programThe 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. |
| Second APA program | Active comparator | Other: Adapted physical activity self-programOur 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adapted physical activity programRehabilitation | Other | First APA program |
| Adapted physical activity self-programRehabilitation | Other | Second APA program |
Primary outcome
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
9 secondary outcomes
the rate physical activities in Written report
Time frame: 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)
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)
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)
Borg Rating Scale of Exertion
Time frame: 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)
Berg Balance Scale (BBS)
Time frame: 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)
Behavioral regulation in exercise questionnaire
Time frame: at inclusion Day and at the 13th week (and the 26th week for one group only)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
- Derived from this study: PubMed 39032927Satger E, Prieur-Blanc N, Viton JM, Auquier P, Bensoussan L, Cotinat M. Effectiveness of an institution-based adapted physical activity programme versus a home-based self-management programme for chronic poststroke adults: protocol for a randomised controlled study. BMJ Open. 2024 Jul 20;14(7):e084688. doi: 10.1136/bmjopen-2024-084688.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted physical activity program and Adapted physical activity self-program in people with Stroke, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maeva COTINAT (04 91 74 42 00, maeva.cotinat@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily activity measurement (time frame: through study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.