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Recruiting NCT07084025

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

No phase Interventional Stroke Cerebrovascular Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I).
Who it may be relevant to
Registry conditions: Stroke, Cerebrovascular Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Feasibility of Home-based Cognitive Strategy Training for Independence of Activities of Daily Living in Adults With Chronic Stroke

Overview

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.

Interventions

  • Other 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

Primary outcome measures

  • Feasability [Time frame: From enrollment to the end of intervention at 4 weeks]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • University Hospital of Toulouse — Toulouse

Identifiers

NCT: NCT07084025 · RC31/24/0579

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗