Robotic Technologies for APATHy in Dementia: a Randomised Controlled Trial (RAPHAel)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in apathy severity
研究概览
简要总结
The goal of this trial is to learn whether home-based robotic interventions can reduce apathy in people with cognitive decline. Apathy means reduced motivation, interest, or initiative in daily life. It is a common and distressing symptom in people with mild cognitive impairment (MCI) or dementia and can strongly affect both participants and their caregivers.
This study will compare two different robotic interventions with standard occupational therapy. Researchers want to understand if these new technologies can help people become more engaged, motivated, and involved in everyday activities, and whether they also reduce stress and improve quality of life for caregivers.
The main questions this study aims to answer are:
- Do robotic interventions reduce apathy more than standard occupational therapy?
- Are these robotic interventions easy to use and acceptable for people with cognitive impairment?
- Do these interventions reduce caregiver stress and improve caregiver quality of life?
Participants will be adults over 40 years of age with a diagnosis of mild cognitive impairment or dementia caused by a neurodegenerative disease, such as Alzheimer's disease, frontotemporal dementia, or dementia with Lewy bodies. All participants must show clinically relevant apathy and have a family member or caregiver who can support them during the study and answer questionnaires.
Participants will be randomly assigned to one of three groups:
- A telepresence robot group, where participants interact at home with a therapist through a remotely controlled robot that delivers personalized cognitive stimulation.
- A social robot group, where participants interact at home with a humanoid robot that holds personalized conversations on topics of interest.
- A control group receiving home-based occupational therapy, which is the current standard care for behavioral symptoms.
Each intervention lasts six weeks and takes place in the participant's home. The robotic interventions are designed to fit into daily routines and can be adapted to the participant's abilities and preferences. Occupational therapy sessions focus on meaningful activities, environmental adaptations, and caregiver support.
Participants will complete assessments at three time points: before the intervention, at the end of the six-week intervention, and eight weeks after the intervention ends. These assessments include interviews, questionnaires, and simple tasks to measure apathy, emotional responses, social interaction, and quality of life. Caregivers will also complete questionnaires about stress and daily burden.
Researchers will also collect information about how often and how participants interact with the robots, such as how long conversations last and how engaged participants appear. These data will help researchers understand how robotic interactions relate to changes in apathy and behavior.
This study aims to provide evidence on whether robotic technologies can be safely and effectively used at home to support people with cognitive impairment and apathy. The results may help develop new non-drug treatments and improve care options for people living with dementia and their caregivers.
详细描述
Apathy is one of the most common behavioral symptoms associated with neurodegenerative disorders, including mild cognitive impairment (MCI) and dementia. It is characterized by diminished motivation, reduced initiation of activities, emotional blunting, and decreased social engagement. Apathy is associated with faster functional decline, reduced quality of life, increased caregiver burden, and limited response to currently available pharmacological treatments. For these reasons, non-pharmacological interventions are considered a priority target for clinical research.
This randomized controlled trial investigates the effectiveness of two home-based robotic interventions compared with standard occupational therapy for the management of apathy in individuals with cognitive decline. The study is conducted within a multi-center academic and clinical framework and follows international standards for interventional research, including SPIRIT recommendations and Good Clinical Practice principles.
The study adopts a single-blind, three-arm randomized design. Participants are randomly assigned in a 1:1:1 ratio to one of two experimental robot-based interventions or to an active control intervention consisting of home-based occupational therapy. Outcome assessments are performed by evaluators who are blinded to treatment allocation, while participants and intervention providers are aware of the assigned intervention due to the nature of the study.
The first experimental intervention uses a telepresence robotic system operated remotely by a trained researcher or therapist. Through this system, participants receive structured and personalized cognitive stimulation sessions delivered at home. The intervention protocol is based on evidence-supported cognitive rehabilitation programs and includes multiple weekly sessions over a six-week period. The telepresence robot enables real-time audiovisual interaction while allowing the operator to navigate the home environment, supporting engagement and continuity of care.
The second experimental intervention involves a social humanoid robot deployed in the participant's home. The robot is connected to a dedicated conversational server that enables personalized verbal and non-verbal interactions. The system adapts conversations to the participant's interests, personal history, and interaction patterns. Interactions may be initiated by the participant or proactively by the robot, with the aim of stimulating conversational initiative, social engagement, and sustained attention. The frequency and duration of interactions are flexible within the predefined intervention period, allowing the intervention to integrate into daily routines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years or older
- •Clinical diagnosis of a neurocognitive disorder, including: Mild cognitive impairment (MCI) or mild behavioral impairment (MBI), or Major neurocognitive disorder (dementia), due to Alzheimer's disease, frontotemporal dementia, dementia with Lewy bodies, or other neurodegenerative diseases.
- •Presence of clinically relevant apathy, defined as a score greater than 2 on the apathy domain (G) of the Neuropsychiatric Inventory (NPI).
- •Preserved ability to understand and produce spoken and written language sufficient to participate in the intervention and assessments.
- •Absence of clinically significant agitation or aggressiveness, defined as a score lower than 2 on the agitation/aggression domain (C) of the NPI.
- •Adequate educational and occupational history sufficient to exclude intellectual disability.
- •Availability of a study partner (family member, friend, or caregiver) who: Knows the participant well, Has contact with the participant for at least 10 hours per week, Is able to complete questionnaires about the participant, Is able to read, understand, and speak Italian, and Provides independent informed consent for participation.
- •Ability and willingness of the participant (and study partner, when applicable) to provide informed consent.
排除标准
- •Refusal or withdrawal of informed consent by the participant or the study partner.
- •History or current evidence of neurological conditions other than the target neurodegenerative diseases that may affect cognitive function (e.g., major stroke, brain tumor, normal pressure hydrocephalus, traumatic brain injury).
- •History or current diagnosis of major psychiatric disorders that could interfere with study participation or assessments.
- •Presence of medical conditions that may significantly affect cognitive function (e.g., severe renal or hepatic failure, untreated obstructive sleep apnea, hypothyroidism, vitamin B12 deficiency).
- •Clinically significant agitation or aggressiveness, defined as a score of 2 or higher on the agitation/aggression domain (C) of the Neuropsychiatric Inventory (NPI).
- •Inability to understand or communicate in Italian sufficient to complete study procedures.
- •Absence of an eligible study partner or withdrawal of consent by the study partner.
研究组 & 干预措施
telepresence robot
The first experimental intervention uses a telepresence robotic system operated remotely by a trained researcher or therapist. Through this system, participants receive structured and personalized cognitive stimulation sessions delivered at home. The intervention protocol is based on evidence-supported cognitive rehabilitation programs and includes multiple weekly sessions over a six-week period. The telepresence robot enables real-time audiovisual interaction while allowing the operator to navigate the home environment, supporting engagement and continuity of care.
干预措施: Occupational Therapy (Behavioral)
social robot
The second experimental intervention involves a social humanoid robot deployed in the participant's home. The robot is connected to a dedicated conversational server that enables personalized verbal and non-verbal interactions. The system adapts conversations to the participant's interests, personal history, and interaction patterns. Interactions may be initiated by the participant or proactively by the robot, with the aim of stimulating conversational initiative, social engagement, and sustained attention. The frequency and duration of interactions are flexible within the predefined intervention period, allowing the intervention to integrate into daily routines.
干预措施: Pepper robot connected to a CAIR server (Device)
occupational therapy
The active control intervention consists of a structured home-based occupational therapy program targeting behavioral symptoms. This intervention focuses on meaningful activities, environmental adaptations, caregiver education, and strategies to support participation and motivation in daily life. The occupational therapy protocol reflects current standards of care and is delivered over the same six-week timeframe as the experimental interventions.
干预措施: telepresence robotic system (Device)
结局指标
主要结局
Change in apathy severity
时间窗: Baseline to 6 weeks
Change in apathy severity measured by the Apathy Evaluation Scale (AES) total score, assessed from baseline (T0) to end of intervention at 6 weeks (T1).
次要结局
- Caregiver burden(Baseline, 6 weeks)
- caregiver quality of life(Baseline, 6 weeks)
- social cognition(0 to 6 weeks)
研究者
Giovanna Zamboni
Full Professor of Neurology | Department of Biomedical, Metabolic and Neural Sciences | University of Modena and Reggio Emilia; Consultant Neurologist | AOU Modena
University of Modena and Reggio Emilia