PARO: Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- changes in quality of life
研究概览
简要总结
The overall objective of the study is to evaluate the improvement in patient-perceived quality of life following the use of the Paro robot integrated with traditional intervention in the elderly with dementia.
详细描述
The primary aim of this study is to evaluate the patient-perceived improvement in terms of quality of life through Quality of Life - Alzheimer's Disease (QoL-AD), following the use of the Paro robot, integrated with traditional intervention carried out within the IRCCS INRCA Alzheimer's Day Center.
The Secondary aims are the evaluation of the improvement in cognitive status of the elderly person with dementia, in terms of orientation, attentional-executive, mnestic and visuospatial functions, detected through the Addenbrooke's Cognitive Examination (ACE-R); the assessment of mood improvement in terms of reduction of anxiety and depression, detected through the Rating Anxiety In Dementia (RAID) scale and the Cornell Scale for Depression in Dementia (CSDD); the assessment of the elderly person's acceptance of the technology through Quebec User Evaluation of Satisfaction (QUEST 2.0), semi-structured interview and analysis of physiological activation during interaction, with the Noldus Face Reader system and direct observation by the operator; the analysis of behavioral symptomatology through Neuropsychiatric Inventory (NPI); the assessment of practitioner's acceptance of technology through Technology Acceptance Model (TAM) and the assessment of job quality through semi-structured interview.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild-moderate dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V).
- •MMSE between 10 and 24
- •Attending the Alzheimer's Day Center since at least 3 months
- •Presence of a caregiver
排除标准
- •Severe sensory disabilities (visual and auditory)
- •Comprehension difficulties
- •History of syncopal episodes, epilepsy, and dizziness not controlled pharmacologically
- •Severe autonomic system dysfunction
- •Severe behavioral syndromes not compensated by medication
研究组 & 干预措施
Control Group
The Control Group will receive only the traditional therapy.
Experimental Group
The Experimental Group will receive for 12 weeks a robotic training with Paro robot combined with traditional training.
干预措施: PARO robot (Device)
结局指标
主要结局
changes in quality of life
时间窗: baseline, 12 and 24 weeks later
This outcome will be assesed by the Quality of life in Alzheimer's Disease (QoL-AD) test. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.
次要结局
- changes in mood(baseline, 12 and 24 weeks later)
- changes in signs and symptoms of major depression(baseline, 12 and 24 weeks later)
- changes in acceptance of the technology(baseline, 12 and 24 weeks later)
- changes in cognitive status(baseline, 12 and 24 weeks later)