RecruitingNot ApplicableNCT07251517

Cognitive Rehabilitation in Post-stroke Cognitive Impairment

Cognitive Impairment Post Stroke: a Single-blinded Randomized Trial on the Efficacy of TEleRehabilitation. The CIPS-TER Study

Sponsor

University of Florence

Enrollment

100 participants

Start Date

Apr 22, 2024

Study Type

INTERVENTIONAL

Conditions

Cognitive Impairment

Summary

The goal of this 2-year, prospective, single-blind randomized clinical trial is to investigate: the efficacy in reducing the risk of cognitive impairment 6 months after stroke; the generalizability of cognitive reinforcement to real life, such as activities of daily living and quality of life; and the impact on cognitive performance. In the treatment group, feasibility, adherence, and satisfaction with the cognitive telerehabilitation program will also be evaluated. Participants will be adult patients with a diagnosis of ischemic or hemorrhagic stroke, within 5-21 days after onset. The main outcomes to be evaluated are: * diagnosis of cognitive impairment (primary outcome); * activities of daily living, quality of life, changes in frailty status, and cognitive efficiency (secondary outcomes). There will be two groups: a treatment group and a control group. Participants in the treatment group will undergo a cognitive telerehabilitation program of 40 hours over 8 weeks, while participants in the control group will be instructed to follow their standard care.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Age ≥ 18 years
Diagnosis of ischemic or hemorrhagic stroke between 5 and 21 days after the event
Ability to express written informed consent
Evidence of impairment of global cognitive efficiency according to the post-stroke MoCA (MoCA total score≤21)
Normal stenia of at least one upper limb (NIHSS motor item of at least one upper limb=0)

Exclusion Criteria3

Pre-existing dementia (IQ-CODE\>3.48 and/or diagnosis of dementia by a specialist).
Severe aphasia (NIHSS language item ≥2 and impaired performance on the Token test, i.e. a correct score below the 5th centile of the normal population).
Withdrawal of informed consent

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Interventions

PROCEDURECognitive telerehabilitation treatment

The subjects who will be part of the experimental group will receive a total of up to 40 hours of individual treatment. Cognitive telerehabilitation will be administered in five weekly sessions of 60 minutes each for a total of 8 weeks. The cognitive treatment will include twenty-four exercises aimed at improving memory, attention, executive functions and visuospatial skills. In each treatment session, participants will work with six exercises, lasting 10 minutes each, and the difficulty of the task will increase adaptively over the course of the home sessions.