Cognitive Rehabilitation in Post-stroke Cognitive Impairment

NCT ID: NCT07251517

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2026-02-28

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.

Detailed Description

Despite its social and economic burden, cognitive impairment after stroke is still a neglected consequence compared to other neurological deficits for which rehabilitation pathways are routinely available. Cognitive telerehabilitation represents an emerging, promising and innovative approach that has the potential to provide both an individualized treatment and the opportunity of access to services for a wide catchment area.

CIPS-TER study is a 2-year prospective, single-blind, randomized clinical trial. A cognitive telerehabilitation program, versus standard care, will be administered to a cohort of stroke patients with the aims to investigate: efficacy in reducing the risk of cognitive impairment 6 months after stroke; generalizability of the cognitive reinforcement to real life, such as activities in daily living and quality of life; and impact on cognitive performances. In the treated group, feasibility, adherence and appreciation of the cognitive telerehabilitation program will also be evaluated. During an enrolment period of 12 months, all adult patients consecutively admitted to Stroke Unit of Careggi University Hospital and/or to Intensive Rehabilitation Unit of IRCCS Don Gnocchi in Florence with a diagnosis of ischemic or hemorrhagic stroke will be evaluated, within 5-21 days after onset, for the inclusion in the study.

After baseline assessment, the foreseen cohort of 100 enrolled patients will be randomly assigned to treatment or control group. The cognitive telerehabilitation program (Virtual Reality Rehabilitation System, Khymeia) will consist of up to 40 hours (8 weeks) of individual treatment based on memory, attention and executive functions, and visuospatial tasks to be to autonomously performed with a tablet. All patients will be followed after 2 months (brief cognitive assessment) and after 6 months (comprehensive clinical, functional, and cognitive assessment). The study outcomes will be evaluated at 6-month follow-up visit and will include the diagnosis of cognitive impairment (primary outcome), and activities of daily living, quality of life, changes in frailty status and cognitive efficiency (secondary outcomes). The results of CIPS-TER study will contribute to our knowledge on the potentials of an early cognitive telerehabilitation on the reduction of persistent cognitive and functional burden in stroke patients, and thus on the utility to consider cognitive telerehabilitation as an effective component of post-stroke care pathways. In line with precision medicine, CIPS-TER project could also help to highlight which clinical features characterize those stroke patients that could maximally benefit of such cognitive interventions. Finally, experiences and setups gathered within CIPS-TER project could represent a technical and methodological background for future studies aimed at the development and/or the evaluation of cognitive telerehabilitation systems in stroke patients.

Conditions

Cognitive Impairment; Stroke Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive telerehabilitation treatment

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.

Group Type: EXPERIMENTAL

Cognitive telerehabilitation treatment

Intervention Type: 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.

Standard Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: collaborator

University of Pavia

OTHER

Sponsor Role: collaborator

University of Florence

OTHER

Sponsor Role: lead

Responsible Party

Anna Poggesi

Associate professor, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Florence

Florence, Firenze, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Anna Poggesi, Associate Professor, PhD

Role: CONTACT

anna.poggesi@unifi.it

+39 0552751767

Facility Contacts

Anna Poggesi, Professore associato, PhD

Role: primary

anna.poggesi@unifi.it

+39 0552751767

Other Identifiers

25546

Identifier Type: -

Identifier Source: org_study_id