Telerehabilitation in Alzheimer's Disease

NCT07722169 | Not Yet Recruiting DMC

• 1 other identifier: RF-2024-12380126 VRTAD
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Telemedicine has developed rapidly during the COVID-19 pandemic and is now integrated into the clinical practice of many hospitals. Telemedicine offers many advantages, and even after the end of the pandemic, many patients still choose to undergo healthcare visits remotely. However, the rapid expansion of telemedicine may be associated with the risk of providing patients with unvalidated and uncontrolled telehealth solutions, potentially negatively impacting their health. In this study, the researchers aim to investigate the effectiveness of remote cognitive training in patients with mild-to-moderate Alzheimer's disease (AD) using tablets equipped with virtual reality-based cognitive exercises. The investigators also aim to evaluate the impact of online supervision of cognitive training by a neuropsychologist and to compare the costs and burden of home-based versus hospital-based cognitive training in patients with AD. This project will define the optimal modalities for cognitive telerehabilitation to ensure validated protocols for the continuity of care in AD.

Conditions

Alzheimer

Keywords

cognitive training; telerehabilitation; virtual reality; Alzheimer's disease; Cognitive functions; caregiver

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  MoCA is a screening instrument to detect cognitive impairment. It generates a total score and six domain-specific index scores: (1) Memory, (2) Executive Functioning, (3) Attention, (4) Language, (5) Visuospatial, and (6) Orientation. The total possible score is 30 points; a score of 26 or above is considered normal, while scores below 26 may indicate cognitive impairment. Increase in MoCA scores meaning improvement in cognitive functioning.

  (1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.

Secondary Outcomes (16)

• Electroencephalographic (EEG) activity

  (1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.

• Caregivers' mental status

  (1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.

• Caregivers' burden

  (1) before telerehabilitation, (2) after the 3 month-rehabilitation period and (3) at 3 months follow-up after the end of treatment.

• System usability

  At the post 3 month-treatment visit

• Telerehabilitation's costs

  At 3 months follow-up.

Study Arms (3)

Tablet + Telerehabilitation

EXPERIMENTAL

Group 1: Participants will perform autonomous home-based cognitive training using a VRRS tablet (Khymeia Home Tablet) for 5 days per week, combined with online cognitive telerehabilitation sessions conducted twice weekly by a neuropsychologist based at San Raffaele Hospital (telemedicine sessions delivered remotely between the patient's home and the hospital). The intervention will last 3 months.

Device: Home-based cognitive training with VRRS tablets combined with online sessions of cognitive telerehabilitation

Tablet only

EXPERIMENTAL

Group 2: Participants will perform autonomous home-based cognitive training using a VRRS tablet (Khymeia Home Tablet) for 5 days per week. No cognitive telerehabilitation sessions supervised by a neuropsychologist will be provided. The intervention will last 3 months.

Device: Home-based cognitive training with VRRS tablets alone

Telerehabilitation only

NO INTERVENTION

Group 3: Participants will receive online cognitive telerehabilitation sessions supervised by a neuropsychologist twice weekly (telemedicine sessions delivered remotely between the patient's home and the hospital). Participants will not receive a VRRS tablet and will not perform additional autonomous home-based cognitive training.

Interventions

Home-based cognitive training with VRRS tablets combined with online sessions of cognitive telerehabilitation DEVICE

Patients will be equipped with VRRS tablets to undergo autonomous home-based cognitive training (5 days a week), in addition with online sessions of cognitive telerehabilitation, twice a week, supervised by a neuropsychologist based at the San Raffaele hospital.

Tablet + Telerehabilitation

Home-based cognitive training with VRRS tablets alone DEVICE

Patients equipped with VRRS tablets to undergo autonomous home-based cognitive training (5 days a week), without any cognitive telerehabilitation supervised by a neuropsychologist.

Tablet only

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 50 and 90 years.
• Diagnosis of Alzheimer's disease according to established diagnostic criteria.
• Mini-Mental State Examination (MMSE) score between 18 and 24.
• Stable pharmacological treatment for at least 3 months before enrolment.
• Ability and willingness to provide written informed consent.
• Age ≥18 years.
• Availability to assist the patient throughout the study.
• Ability and willingness to provide written informed consent.

You may not qualify if:

• Refusal or inability to provide written informed consent.
• History of psychiatric disorders.
• Significant cerebrovascular disease.
• Severe visual or hearing impairment that could interfere with study procedures.
• Psychosis.
• Major depressive disorder.
• Alcohol or substance abuse.
• Use of psychotropic medications that may interfere with neuropsychological assessment or study treatment.
• Concurrent participation in another interventional pharmacological clinical trial.
• Any contraindication to undergoing EEG recording.
• Refusal or inability to provide written informed consent.
• History of psychiatric disorders.
• Major depressive disorder.
• Alcohol or substance abuse.
• Use of psychotropic medications that may interfere with neuropsychological assessment.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Related Publications (9)

• Gatica-Rojas V, Mendez-Rebolledo G. Virtual reality interface devices in the reorganization of neural networks in the brain of patients with neurological diseases. Neural Regen Res. 2014 Apr 15;9(8):888-96. doi: 10.4103/1673-5374.131612.

  PMID: 25206907 BACKGROUND

• Yang JG, Thapa N, Park HJ, Bae S, Park KW, Park JH, Park H. Virtual Reality and Exercise Training Enhance Brain, Cognitive, and Physical Health in Older Adults with Mild Cognitive Impairment. Int J Environ Res Public Health. 2022 Oct 15;19(20):13300. doi: 10.3390/ijerph192013300.

  PMID: 36293881 BACKGROUND

• Laver KE, George S, Thomas S, Deutsch JE, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2015 Feb 12;2015(2):CD008349. doi: 10.1002/14651858.CD008349.pub3.

  PMID: 25927099 BACKGROUND

• Buschert V, Bokde AL, Hampel H. Cognitive intervention in Alzheimer disease. Nat Rev Neurol. 2010 Sep;6(9):508-17. doi: 10.1038/nrneurol.2010.113. Epub 2010 Aug 17.

  PMID: 20717104 BACKGROUND

• Emedoli D, Houdayer E, Della Rosa PA, Zito A, Brugliera L, Cimino P, Padul JD, Tettamanti A, Iannaccone S, Alemanno F. Continuity of care for patients with dementia during COVID-19 pandemic: flexibility and integration between in-person and remote visits. Front Public Health. 2024 Jan 8;11:1301949. doi: 10.3389/fpubh.2023.1301949. eCollection 2023.

  PMID: 38259745 BACKGROUND

• Emedoli D, Alemanno F, Houdayer E, Brugliera L, Iannaccone S, Tettamanti A. Mobile application tool for remote rehabilitation after discharge from coronavirus disease-19 rehabilitation unit. Healthc Technol Lett. 2022 Aug 8;9(4-5):70-76. doi: 10.1049/htl2.12033. eCollection 2022 Aug-Oct.

  PMID: 36225346 BACKGROUND

• Elbaz S, Cinalioglu K, Sekhon K, Gruber J, Rigas C, Bodenstein K, Naghi K, Lavin P, Greenway KT, Vahia I, Rej S, Sekhon H. A Systematic Review of Telemedicine for Older Adults With Dementia During COVID-19: An Alternative to In-person Health Services? Front Neurol. 2021 Dec 14;12:761965. doi: 10.3389/fneur.2021.761965. eCollection 2021.

  PMID: 34970210 BACKGROUND

• Grabher BJ. Effects of Alzheimer Disease on Patients and Their Family. J Nucl Med Technol. 2018 Dec;46(4):335-340. doi: 10.2967/jnmt.118.218057. Epub 2018 Aug 23.

  PMID: 30139888 BACKGROUND

• Manenti R, Gobbi E, Baglio F, Macis A, Ferrari C, Pagnoni I, Rossetto F, Di Tella S, Alemanno F, Cimino V, Binetti G, Iannaccone S, Bramanti P, Cappa SF, Cotelli M. Effectiveness of an Innovative Cognitive Treatment and Telerehabilitation on Subjects With Mild Cognitive Impairment: A Multicenter, Randomized, Active-Controlled Study. Front Aging Neurosci. 2020 Nov 16;12:585988. doi: 10.3389/fnagi.2020.585988. eCollection 2020.

  PMID: 33304267 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Elise Houdayer, PhD

CONTACT

+390226435739; houdayer.elise@hsr.it

Sandro Iannaccone, MD

CONTACT

+390226435760; iannaccone.sandro@hsr.it

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: Dr

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share