Personalized robotic interventions for apathy in dementia: the RAPHAel trial

Apathy is common in individuals with mild cognitive impairment (MCI) or dementia and mild behavioral impairment (MBI), and is associated with reduced quality of life and increased caregiver burden. Home-based robot-assisted interventions offer a novel approach for cognitive stimulation and behavioral management, but robust evidence on feasibility, acceptability, and clinical impact is limited.

To evaluate the effects of home-based robotic interventions on the level of apathy in individuals with cognitive decline, including MCI, MBI, and dementia. Secondary objectives are to assess the usability of the robotic devices and the extent of patients' interactions with and through these technologies, as well as to evaluate the effects of the robotic interventions on caregivers' stress levels and quality of life.

This single-blind, randomized controlled trial includes three arms: two experimental robot-assisted interventions (tele-operated cognitive stimulation and humanoid robot) and an active control group receiving occupational therapy, which represents the current gold-standard intervention. Eighty patients with MCI, MBI, or dementia, and clinically significant apathy, together with their study partners, will be recruited from neurology, geriatrics, and neurorehabilitation centers in Italy. Each intervention will last 6 weeks. Assessments will be performed at baseline (T0), post-intervention (T1), and follow-up (T2) and will include clinical questionnaires, cognitive and social cognition tasks, and sensor-based measures of social grasping.

This study will provide evidence on the potential clinical benefits, feasibility, and acceptability of home-based robot-assisted interventions for apathy in cognitive decline, as well as inform the development of digital markers for personalized monitoring and intervention.