StrokeLARAQSNCT05772663
A Rehabilitation Program Based on Daily Activities in Patients With Cerebrovascular Accident
A study testing Personalized program of rehabilitation and Routine program of rehabilitation in people with Stroke, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Mixed qualitative and quantitative study, in two phases: Creation of a self-rehabilitation program based on people's daily living activities and designed with and for them. Randomized controlled study to explore whether there is a potential benefit for patients with chronic stroke to use a self-rehabilitation program. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Personalized program of rehabilitation and Routine program of rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2025to Sep 2028
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having had a stroke ischemic or hemorrhagic for more than 6 months before inclusion in the study.
- Having had a single cerebral hemispheric lesion
- Patient informed and having signed consent
Who cannot join
- -Patient under guardianship or curatorship
- Pregnant or breastfeeding women
- Cognitive impairment defined by BDAE <3
- Previous operation of the paretic limb at course of the last 6 months at inclusion
- Total absence of motor skills in the upper limb hemiplegic
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
New Technilogy Platform department, Raymond Poincaré hospital - APHP
Garches, 92380
About this study
Official title: Elaboration and Evaluation of a Program of Self-rehabilitation Based on Daily Living Activities in Patients With Chronic Stroke
Mixed qualitative and quantitative study, in two phases:
Creation of a self-rehabilitation program based on people's daily living activities and designed with and for them.
Randomized controlled study to explore whether there is a potential benefit for patients with chronic stroke to use a self-rehabilitation program.
Read the detailed description
In France, stroke affects nearly 150,000 people per year and is therefore a major problem public health in France but also in Europe . With improved support treatment, the mortality rate decreases, but the sequelae, linked to the consequences of the stroke, remain numerous . More than 88% of stroke victims return at home upon discharge from hospital rehabilitation. However more and more people experience difficulties as a result of this return. Hospital discharge entails an imbalance between the period of hospitalization and place of residence in terms of the frequency and intensity of rehabilitation. In fact, the person benefits from rehabilitation during his hospitalization daily. After returning home, the person no longer benefits only 1 to 2 rehabilitation sessions per week, sometimes less . In view of these different elements, the investigators issue the assumption that making available to people AVC a self-rehabilitation program designed with and for them and centered on the meaningful occupations of the person will allow an increase in their occupational performance in their life activities daily. The aim of this study is to create a self-rehabilitation program based on people's daily living activities and designed with and for them and to evaluate the benefits of this program with a randomized controlled study.
- Conditions
- Stroke
- Being tested
- Personalized program of rehabilitation, Routine program of rehabilitation
- Keywords
- Stroke, self-rehabilitation program
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized program of rehabilitationOther
D56: Follow-up visit (D56). Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis.
Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands.
D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20*20). At D119, the person returns the accelerometric writbands.
Routine program of rehabilitationOther
Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis.
Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands.
D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20*20). At D119, the person returns the accelerometric writbands.
| Study group | Role | What they receive |
|---|---|---|
| personalized program group | Experimental | people with chronic stroke Receives: Other: Personalized program of rehabilitation |
| routine rehabilitation care group | Active comparator | people with chronic stroke Receives: Other: Routine program of rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Motor and Process Skills AMPS°
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Measured: Day -7
Assessment of Motor and Process Skills AMPS°
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Measured: Day 0
Assessment of Motor and Process Skills AMPS°
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Measured: Day 56
Assessment of Motor and Process Skills AMPS°
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Measured: Day112
Secondary outcomes (11)
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: Day -7
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: Day 0
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: Day 56
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.
Measured: Day 112
Satisfaction. Visual Analogic Scale (Satisfaction VAS)
To assess post-stroke satisfaction with the program, we will use a Visual Analog Scale (0-10)
Measured: D56
program acceptance score
Acceptance questionnaire
Measured: Day 56
program acceptance score
Acceptance questionnaire
Measured: Day 112
Quantity of acceleration (accelerometer wristbands)
Quantity of acceleration per upper limb (number of acceleration) It will be established on the basis of an accelerometer wearing time of 168 hours (7 days continuously).
Measured: Day-7
Quantity of acceleration (accelerometer wristbands)
Quantity of acceleration per upper limb (number of acceleration) It will be established on the basis of an accelerometer wearing time of 168 hours (7 days continuously).
Measured: Day 56
Quantity of acceleration (accelerometer wristbands)
Quantity of acceleration per upper limb (number of acceleration) It will be established on the basis of an accelerometer wearing time of 168 hours (7 days continuously).
Measured: Day 112
Time spent doing the program
To assess adherence to the self-rehabilitation program, investigators will use a monitoring notebook completed by the person with stroke on the follow-up of sessions / self-rehabilitation time.
Outcome measure in time (hours per week)
Measured: at the end of the study, un average of 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study startNov 2025 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samuel POUPLIN, PhD, Principal investigator, New technology Platform department, Raymond Poincaré hospital -APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772663
- Sponsor's protocol ID
- APHP220833
- Other IDs
- 2023-A00302-43
- Acronym
- LARAQS
- Status last verified
- Sep 2025
- First submitted
- 10 Feb 2023
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration and Evaluation of a Program of Self-rehabilitation Based on Daily Living Activities in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT05772663
- Acronym / sponsor ID
- LARAQS / APHP220833
- Conditions
- Stroke
- Keywords
- Stroke, self-rehabilitation program
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 16 Mar 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.
Mixed qualitative and quantitative study, in two phases:
Creation of a self-rehabilitation program based on people's daily living activities and designed with and for them.
Randomized controlled study to explore whether there is a potential benefit for patients with chronic stroke to use a self-rehabilitation program.
Detailed description
In France, stroke affects nearly 150,000 people per year and is therefore a major problem public health in France but also in Europe . With improved support treatment, the mortality rate decreases, but the sequelae, linked to the consequences of the stroke, remain numerous . More than 88% of stroke victims return at home upon discharge from hospital rehabilitation. However more and more people experience difficulties as a result of this return. Hospital discharge entails an imbalance between the period of hospitalization and place of residence in terms of the frequency and intensity of rehabilitation. In fact, the person benefits from rehabilitation during his hospitalization daily. After returning home, the person no longer benefits only 1 to 2 rehabilitation sessions per week, sometimes less . In view of these different elements, the investigators issue the assumption that making available to people AVC a self-rehabilitation program designed with and for them and centered on the meaningful occupations of the person will allow an increase in their occupational performance in their life activities daily. The aim of this study is to create a self-rehabilitation program based on people's daily living activities and designed with and for them and to evaluate the benefits of this program with a randomized controlled study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personalized program group | Experimental | Other: Personalized program of rehabilitationpeople with chronic stroke |
| routine rehabilitation care group | Active comparator | Other: Routine program of rehabilitationpeople with chronic stroke |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having had a stroke ischemic or hemorrhagic for more than 6 months before inclusion in the study.
- Having had a single cerebral hemispheric lesion
- Patient informed and having signed consent
Key exclusion criteria (5 listed)
- -Patient under guardianship or curatorship
- Pregnant or breastfeeding women
- Cognitive impairment defined by BDAE <3
- Previous operation of the paretic limb at course of the last 6 months at inclusion
- Total absence of motor skills in the upper limb hemiplegic
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 |
|---|---|---|
| Personalized program of rehabilitationD56: Follow-up visit (D56). Assessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis. Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands. D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20*20). At D119, the person returns the accelerometric writbands. | Other | personalized program group |
| Routine program of rehabilitationAssessments: AMPS, MCRO, Satisfaction VAS. Installation of accelerometer wristbands for the sub-sample of 40 people with stroke drawn at random secondary accelerometry analysis. Between D56 and D112: For 8 weeks, the person does not receive any intervention apart from their usual rehabilitation. At D63, the person returns the accelerometric wristbands. D112: The assessments carried out by occupational therapist are: AMPS, MCRO. Installation of accelerometer bracelets for the sub-sample of 40 people with stroke, randomly selected for secondary analysis on accelerometers (subjects from the two groups, experimental and control, i.e. 20*20). At D119, the person returns the accelerometric writbands. | Other | routine rehabilitation care group |
Primary outcome
Assessment of Motor and Process Skills AMPS°
Time frame: Day -7
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Assessment of Motor and Process Skills AMPS°
Time frame: Day 0
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Assessment of Motor and Process Skills AMPS°
Time frame: Day 56
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
Assessment of Motor and Process Skills AMPS°
Time frame: Day112
The Assessment of Motor and Process Skills (AMPS) is an observational assessment that allows for the simultaneous evaluation of motor and process skills and their effect on the ability of an individual to perform complex or instrumental and personal activities of daily living (ADL). The AMPS is comprised of 16 motor and 20 process skill items.
11 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: Day -7
Canadian Occupational Performance Measure (COPM)
Time frame: Day 0
Canadian Occupational Performance Measure (COPM)
Time frame: Day 56
Canadian Occupational Performance Measure (COPM)
Time frame: Day 112
Satisfaction. Visual Analogic Scale (Satisfaction VAS)
Time frame: D56
program acceptance score
Time frame: Day 56
program acceptance score
Time frame: Day 112
Quantity of acceleration (accelerometer wristbands)
Time frame: Day-7
Quantity of acceleration (accelerometer wristbands)
Time frame: Day 56
Quantity of acceleration (accelerometer wristbands)
Time frame: Day 112
Time spent doing the program
Time frame: at the end of the study, un average of 56 days
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 19 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Samuel POUPLIN, PhD principal investigator
New technology Platform department, Raymond Poincaré hospital -APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized program of rehabilitation and Routine program of rehabilitation in people with Stroke, run by Assistance Publique - Hôpitaux de Paris 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 5 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: opening soon, as of the sponsor's last update on 19 Nov 2025. 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 Samuel POUPLIN, PhD (+ 33 01.47.10.70.61, samuel.pouplin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Motor and Process Skills AMPS° (time frame: Day -7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025; AzTrials last refreshed its copy on 2 Nov 2026.