Home-based Cognitive Strategy Training for Daily Living in Adults With Chronic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Perceive, Recall, Plan and Perform-Intervention protocol (PRPP-I)
Other interventiondelivered 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.).
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Perceive, Recall, Plan and Perform-Intervention (PRPP-I)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of intervention at 4 weeksSecondary 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.
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 interventionSponsors and contacts
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Source ClinicalTrials.gov