Effectiveness of Telerehabilitation Plus Virtual Reality App in Patients With Subjective Cognitive Decline, and Mild Cognitive Impairment

Status: Recruiting
Location: See location...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to evaluate the effectiveness of a telerehabilitation program combined with a virtual reality (VR) app in improving cognitive performance and social skills in patients with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI). The main questions it aims to answer are: Can a VR telerehabilitation program improve cognitive functions and social skills in patients with SCD and MCI? Are there measurable changes in brain activity, eye movements, and gait patterns after the intervention? Researchers will compare telerehabilitation with a VR group (Experimental Group - EG) to a traditional paper-based cognitive rehabilitation group (Active Control Group - aCG) to determine which approach is more effective. Participants will: Undergo an initial assessment, including neurological exams, neuropsychological tests, brain MRI, EEG, eye movement analysis, and gait evaluation. Participate in a 6-week intervention program: EG: Use VR apps on smartphones/tablets at home, guided remotely by a therapist. aCG: Perform traditional cognitive exercises using paper-based tasks. Complete follow-up assessments immediately after the intervention and again after three months. This study will help determine whether telerehabilitation with VR can provide measurable cognitive and social benefits, contributing to improved care strategies for individuals at risk of dementia.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• Subjects diagnosed with MCI (AD and PD) according to the criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA, Albert et al., 2011)

• Subjects diagnosed with SCD according to diagnostic criteria proposed in research settings (Molinuevo et al., 2017)

• All enrolled subjects must be aged between 40 and 80 years and have at least 5 years of education

Locations
Other Locations
Italy
IRCCS Centro Neurolesi Bonino Pulejo
RECRUITING
Messina
Contact Information
Primary
Maria Grazia Maggio, PhD, PsyD
mariagrazia.maggio@irccsme.it
+39 090 62128250
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 480
Treatments
Experimental: Tele-VR Group
Participants in this arm will undergo a Telerehabilitation program using Virtual Reality (VR) apps. This intervention is designed to improve cognitive and social cognition skills through interactive, engaging exercises conducted remotely.
Active_comparator: Active Control Group (aCG)
Participants in this arm will receive a traditional cognitive rehabilitation program using paper-based exercises. The intervention targets the same cognitive and social domains as the experimental group but uses conventional rehabilitation methods.
Sponsors
Leads: IRCCS Centro Neurolesi Bonino Pulejo

This content was sourced from clinicaltrials.gov