Home-based Cognitive Strategy Training for Daily Living in Adults With Chronic Stroke

NCT ID: NCT07084025

Last Updated: 2025-07-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.).

Interventions

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.).

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Margot MORIN

Role: CONTACT

morin.mar@chu-toulouse.fr

05 61 77 73 47

Clémence Le Bervet

Role: CONTACT

drci.toulouse@chu-toulouse.fr

0561777087

Other Identifiers

RC31/24/0579

Identifier Type: -

Identifier Source: org_study_id