Cognitive Rehabilitation in Post-stroke Cognitive Impairment

NCT07251517 | Completed DMC

• 1 other identifier: 25546
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Impairment; Stroke Acute

Keywords

cognitive telerehabilitation; stroke; cognitive impairment; neuropsychology

Outcome Measures

Primary Outcomes (1)

• Reduction of the risk of cognitive impairment post stroke in the medium-long term

  The primary endpoint will be the diagnosis of cognitive impairment, which will include both mild cognitive impairment (MCI) and dementia and will be made according to the DSM-5 criteria for the diagnosis of mild or major neurocognitive disorders, respectively.

  From enrollment to 6 months after stroke

Secondary Outcomes (4)

• Quality of life post-stroke

  From enrollment to 6 months after stroke

• Independence in activities of daily living post-stroke

  From enrollment to 6 months after stroke

• Changes in frailty status post-stroke

  From enrollment to 6 months after stroke

• Impact on cognitive performance

  From enrollment to 6 months after stroke

Study Arms (2)

Cognitive telerehabilitation treatment

EXPERIMENTAL

The cognitive telerehabilitation program will be based on the Virtual Reality Rehabilitation System (VRRS) of the Khymeia group (Noventa Padovana, Italy). The VRRS equipment includes a central workstation located in the clinical center and VRRS tablet devices used independently by patients to perform cognitive exercises. The cognitive modules of the VRRS include a broad set of tasks for each major cognitive domain. Tasks can be customized and supervised from the central workstation and comprehensive automatic reports are available for each rehabilitation session.

Procedure: Cognitive telerehabilitation treatment

Standard Care

NO INTERVENTION

Participants in the control group, "standard care", will be instructed to have a usual lifestyle and will receive conventional treatments and clinical indications provided by referring doctors.

Interventions

Cognitive telerehabilitation treatment PROCEDURE

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.

Cognitive telerehabilitation treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pavia: collaborator
• University of Florence: lead
• University of Milan: collaborator

Study Sites (1)

University of Florence

Florence, Firenze, 50134, Italy

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Stroke

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, PhD

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: November 26, 2025
• Study Start: April 22, 2024
• Primary Completion: March 20, 2026
• Study Completion: March 20, 2026
• Last Updated: April 29, 2026

Record last verified: 2025-10

Locations

IT (1)