StrokePRPP-HOMENCT07084025
Home-based Cognitive Strategy Training for Daily Living in Adults With Chronic Stroke
A study testing Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I) in people with Stroke and Cerebrovascular Disorders, run by University Hospital, Toulouse at 1 site in France.
Trial summary
This pilot experimental study aims to describe the feasibility of a cognitive strategy training protocol : PRPP-I, in activities of daily life across home-based setting for adults with chronic stroke for improvement of independence and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Cerebrovascular Disorders
- What is being tested?
- Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jan 2026to 31 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Patient's Main Eligibility criteria:
- Adult over 18 years of age;
- cognitive deficits (or Acquired Brain Injury) diagnosed due to ischemic or hemorrhagic, hemispheric or brainstem stroke, confirmed by brain imaging longer than 6 months;
- Patient with mild (<26/30 or <25/30 for patients aged 71-85 yr) or moderate ([18-25]/30) cognitive impairment, measured by the Montreal Cognitive Assessment test ;
- adults living in a home or community-based setting;
- Patient with a non-professional caregiver;
Patient's Main Exclusion criteria
- Neurological pathology other than stroke or psychiatric disorder;
- Significant cognitive impairment, according to MoCA score <18/30;
- Patient with severe aphasia, Boston Diagnostic Aphasia Examination score >2
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
University Hospital of Toulouse
Toulouse
Claire VILLEPINTE, MD, (+33 5 67 7)7 17 24, villepinte.c@chu-toulouse.fr
About this study
Official title: Feasibility of Home-based Cognitive Strategy Training for Independence of Activities of Daily Living in Adults With Chronic Stroke
This pilot experimental study aims to describe the feasibility of a cognitive strategy training protocol : PRPP-I, in activities of daily life across home-based setting for adults with chronic stroke for improvement of independence and quality of life. Aditionnally to examine preliminary effectiveness of PRPP-I protocol within a home-based setting on functional cognitive strategies, independence, quality of life and career burden.
Read the detailed description
Stroke is the first cause of acquired disability in France causing impairments on independence. Depending on the area damaged, the impairments may vary. Indeed, these disorders can lead to a loss of autonomy and have an impact on independence in daily life activities. Following a stroke, most of patients retain long term consequences. 39 % of patients report cognitive impairment within three years after stroke. The prevalence of a cognitive impairment at 3 months post-stroke is estimated to be between 23 and 55 % impacting participation in daily life and quality of life. Due to reduced autonomy and participation restrictions, stoke patients need human assistance. It's estimated that 8,3 million people regularly provide home care to a dependent family member. Career time has demonstrated to increase with the level of dependency highlighting importance of rehabilitation of cognitive disorders after stroke for independence and caregiver burden prevention. Cognitive training during real-life activities warrants additional interest for improvement of autonomy in adults with stroke. Yet, majority of training is limited to hospital-based settings.
Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I) is aimed at delivering task-based cognitive strategy training during activities appropriate for delivery in home-based setting. The objective of this pilot study is to evaluate feasibility and preliminary effectiveness of the protocol of cognitive task-based strategy training on performance, independence and quality of life in adults with stroke within a home-based setting with a non-concurrent multiple baseline design.
Patients will be followed during 12 weeks over 3 phases. Phase A corresponds to the baseline, during this phase, there is no cognitive intervention. Intervention takes place during phase B. Patients will receive 3 sessions per week, lasting between 45 to 60 min during 4 weeks. PRPP-Intervention aimed at training cognitive strategies in an activity of daily living will be delivered. Subsequently, there will be a follow-up phase, during this period, patients will not have intervention. Assessments will be proposed to evaluate the possible results of the PRPP-Intervention.
- Conditions
- Stroke, Cerebrovascular Disorders
- Being tested
- Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)
- Keywords
- Cognitive strategy training, Task-based, Ecological, Performance, Activities of Daily Living
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)Other
delivered over a 4-week period, in 12 sessions (45/60 min, 3 days a week for 4 weeks) for all patients according to the PRPP-I protocol. The intervention will be carried out by a PRPP-certified occupational therapist working on a Master's degree.
It will consist of :
- Implementation of training in functional cognitive strategies and meta-prompts through performance in home activities,
- Repeated measurement of performance judgment criteria ;
- Assessment of cognitive strategies
- personalized implementation of the PRPP-I cognitive strategy training protocol.
- Collection of feasibility modalities when tracking the intervention (e.g., time, transport, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Perceive, Recall, Plan and Perform-Intervention (PRPP-I) | Experimental | task-based cognitive strategy training during activities appropriate for delivery in home-based setting. Receives: Other: Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability
Composite outcome examine (1) the recruitment, (2) adherence to the protocol, (3) the implementation of the procedures (delivery) of the intervention and (4) the fidelity to intervention.
(1) the adequate recruitment rate will be 9 participants who meet the inclusion criteria, assessed at 24 months; (2) Adherence will be adequate if > 80% of participants complete the PRPP-I protocol at home (≥80% of sessions) for 4 weeks, assessed at 4 weeks post-intervention; (3) Intervention procedures (delivery) will be assessed based on the implementation of resources for 12 PRPP-I intervention sessions delivered at home over 4 weeks, assessed at 4 weeks post-intervention; (4) Intervention fidelity, according to the PRPP-I protocol (i.e., intervention implementation) will be assessed using a standardized checklist. A procedural fidelity of ≥ 80% will be interpreted as adequate, calculated using the Tate \& Perdices formula of 2019 and in accordance with SCRIBE guidelines.
Measured: From enrollment to the end of intervention at 4 weeks
Secondary outcomes (1)
Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is used to assess the level of independence in activities of daily living in adults after stroke. It includes 18 items rated on a 7-point scale, where 1 indicates total assistance and 7 indicates complete independence. Thirteen items assess motor function (such as self-care and mobility), and five items assess cognitive function (such as communication and social interaction).
The total score ranges from 18 (complete dependence) to 126 (complete independence). Motor and cognitive subscores can also be calculated, with maximum scores of 91 and 35 respectively.
The FIM demonstrates good reliability, internal consistency, construct validity, and sensitivity to change. It is commonly used in clinical rehabilitation settings and aligns with current national and international guidelines for post-stroke functional assessment.
Measured: At enrollment, Start of intervention (between 1 and 5 weeks post enrollment), End of intervention (between 5 and 9 weeks post enrollment), and 3-month follow-up post end of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start5 Jan 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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 University Hospital, ToulouseThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SCED (single-case design) in multiple baselines across 9 adults living at home with post-stroke cognitive disorders in chronic phase.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084025
- Sponsor's protocol ID
- RC31/24/0579
- Acronym
- PRPP-HOME
- Status last verified
- May 2026
- First submitted
- 16 Jul 2025
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Home-based Cognitive Strategy Training for Independence of Activities of Daily Living in Adults With Chronic Stroke
- ClinicalTrials.gov ID
- NCT07084025
- Acronym / sponsor ID
- PRPP-HOME / RC31/24/0579
- Conditions
- Stroke, Cerebrovascular Disorders
- Keywords
- Cognitive strategy training, Task-based, Ecological, Performance, Activities of Daily Living
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Jul 2025 (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 pilot experimental study aims to describe the feasibility of a cognitive strategy training protocol : PRPP-I, in activities of daily life across home-based setting for adults with chronic stroke for improvement of independence and quality of life. Aditionnally to examine preliminary effectiveness of PRPP-I protocol within a home-based setting on functional cognitive strategies, independence, quality of life and career burden.
Detailed description
Stroke is the first cause of acquired disability in France causing impairments on independence. Depending on the area damaged, the impairments may vary. Indeed, these disorders can lead to a loss of autonomy and have an impact on independence in daily life activities. Following a stroke, most of patients retain long term consequences. 39 % of patients report cognitive impairment within three years after stroke. The prevalence of a cognitive impairment at 3 months post-stroke is estimated to be between 23 and 55 % impacting participation in daily life and quality of life. Due to reduced autonomy and participation restrictions, stoke patients need human assistance. It's estimated that 8,3 million people regularly provide home care to a dependent family member. Career time has demonstrated to increase with the level of dependency highlighting importance of rehabilitation of cognitive disorders after stroke for independence and caregiver burden prevention. Cognitive training during real-life activities warrants additional interest for improvement of autonomy in adults with stroke. Yet, majority of training is limited to hospital-based settings.
Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I) is aimed at delivering task-based cognitive strategy training during activities appropriate for delivery in home-based setting. The objective of this pilot study is to evaluate feasibility and preliminary effectiveness of the protocol of cognitive task-based strategy training on performance, independence and quality of life in adults with stroke within a home-based setting with a non-concurrent multiple baseline design.
Patients will be followed during 12 weeks over 3 phases. Phase A corresponds to the baseline, during this phase, there is no cognitive intervention. Intervention takes place during phase B. Patients will receive 3 sessions per week, lasting between 45 to 60 min during 4 weeks. PRPP-Intervention aimed at training cognitive strategies in an activity of daily living will be delivered. Subsequently, there will be a follow-up phase, during this period, patients will not have intervention. Assessments will be proposed to evaluate the possible results of the PRPP-Intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SCED (single-case design) in multiple baselines across 9 adults living at home with post-stroke cognitive disorders in chronic phase.
| Arm | Type | Receives |
|---|---|---|
| Perceive, Recall, Plan and Perform-Intervention (PRPP-I) | Experimental | Other: Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)task-based cognitive strategy training during activities appropriate for delivery in home-based setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)delivered over a 4-week period, in 12 sessions (45/60 min, 3 days a week for 4 weeks) for all patients according to the PRPP-I protocol. The intervention will be carried out by a PRPP-certified occupational therapist working on a Master's degree. It will consist of : * Implementation of training in functional cognitive strategies and meta-prompts through performance in home activities, * Repeated measurement of performance judgment criteria ; * Assessment of cognitive strategies * personalized implementation of the PRPP-I cognitive strategy training protocol. * Collection of feasibility modalities when tracking the intervention (e.g., time, transport, etc.). | Other | Perceive, Recall, Plan and Perform-Intervention (PRPP-I) |
Primary outcome
Feasability
Time frame: From enrollment to the end of intervention at 4 weeks
Composite outcome examine (1) the recruitment, (2) adherence to the protocol, (3) the implementation of the procedures (delivery) of the intervention and (4) the fidelity to intervention. (1) the adequate recruitment rate will be 9 participants who meet the inclusion criteria, assessed at 24 months; (2) Adherence will be adequate if > 80% of participants complete the PRPP-I protocol at home (≥80% of sessions) for 4 weeks, assessed at 4 weeks post-intervention; (3) Intervention procedures (delivery) will be assessed based on the implementation of resources for 12 PRPP-I intervention sessions delivered at home over 4 weeks, assessed at 4 weeks post-intervention; (4) Intervention fidelity, according to the PRPP-I protocol (i.e., intervention implementation) will be assessed using a standardized checklist. A procedural fidelity of ≥ 80% will be interpreted as adequate, calculated using the Tate \& Perdices formula of 2019 and in accordance with SCRIBE guidelines.
1 secondary outcome
Functional Independence Measure (FIM)
Time frame: At enrollment, Start of intervention (between 1 and 5 weeks post enrollment), End of intervention (between 5 and 9 weeks post enrollment), and 3-month follow-up post end of intervention
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 8 May 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I) in people with Stroke and Cerebrovascular Disorders, run by University Hospital, Toulouse 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?
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 8 May 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 Margot MORIN (05 61 77 73 47, morin.mar@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability (time frame: From enrollment to the end of intervention at 4 weeks). 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 8 May 2026.