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Home-based Cognitive Strategy Training for Daily Living in Adults With Chronic Stroke (PRPP-HOME)

T

Toulouse University Hospital

Status

Begins enrollment this month

Conditions

Stroke
Cerebrovascular Disorders

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07084025
RC31/24/0579

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

Perceive, Recall, Plan and Perform-Intervention (PRPP-I)
Experimental group
Description:
task-based cognitive strategy training during activities appropriate for delivery in home-based setting.
Treatment:
Other: Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)

Trial contacts and locations

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Central trial contact

Margot MORIN; Clémence Le Bervet

Data sourced from clinicaltrials.gov

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