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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Italy
University of Florence
RECRUITING
Florence
Contact Information
Primary
Anna Poggesi, Associate Professor, PhD
anna.poggesi@unifi.it
+39 0552751767
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2026-02
Participants
Target number of participants: 100
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Milan, University of Pavia
Leads: University of Florence

This content was sourced from clinicaltrials.gov