NCT07084025

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable stroke

Timeline
19mo left

Started Jan 2026

Typical duration for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

July 16, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

January 5, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

July 16, 2025

Last Update Submit

May 7, 2026

Conditions

Keywords

Cognitive strategy trainingTask-basedEcologicalPerformanceActivities of Daily Living

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of intervention at 4 weeks

Secondary Outcomes (1)

  • Functional Independence Measure (FIM)

    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

Study Arms (1)

Perceive, Recall, Plan and Perform-Intervention (PRPP-I)

EXPERIMENTAL

task-based cognitive strategy training during activities appropriate for delivery in home-based setting.

Other: Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)

Interventions

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.).

Perceive, Recall, Plan and Perform-Intervention (PRPP-I)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

StrokeCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: SCED (single-case design) in multiple baselines across 9 adults living at home with post-stroke cognitive disorders in chronic phase.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 24, 2025

Study Start

January 5, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations