A New 360° Dual-task Based Protocol for the Pre-clinical In-hospital and At-home Rehabilitation of Elderly: DUAL-Rehab
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Cognitive functions
研究概览
简要总结
The main objective of this project is two-fold
- to develop a Dual-Task training exploiting the potentiality of the 360° technology in terms of interactivity and ecological validity
- to investigate its efficacy in improving the cognitive functioning in a randomized clinical trial for 2 different populations: subjects with subjective memory complaints and mild cognitive impairment.
Specifically, participants will follow an integrated training including 2 phases: 1)in-hospital rehabilitation, where subjects will be provided sessions of the training in immersive modality; 2)at-home rehabilitation, where older adults will be asked to perform at home the non-immersive version of the training using a tablet.
Expected outcome is an improvement in cognitive functioning (assessed with a complete neuropsychological battery) after the training, thus advancing literature about non-pharmacological interventions in the preclinical stages of dementia along with innovative technical instruments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, 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
- 未提供
排除标准
- •no evidence of objective impairments on the neuropsychological testing, scores on the Clinical Dementia Rating < 0.5
- •Inclusion Criteria (group of MCI):
- •> 65 years old
- •a self-reported (or reported by a caregiver) cognitive decline
- •an objective impairment on the neuropsychological testing
- •scores on the Clinical Dementia Rating < 0.
- •Exclusion Criteria:
- •no dementia
研究组 & 干预措施
360° media
All participants will be randomly assigned to 360° media or TAU condition
干预措施: 360° media (Device)
In hospital sessions
all participants will perform session in hospital
干预措施: In hospital sessions (Other)
at home sessions
all participants will perform session at home
干预措施: at home sessions (Other)
Mild Cognitive Impairment
half of the patients will have MCI
干预措施: Mild Cognitive Impairment (Other)
Subjective Memory Complain
half of the patients will have SMC
干预措施: Subjective Memory Complain (Other)
结局指标
主要结局
Cognitive functions
时间窗: Immediately after the training experience
Improvement in cognitive functioning assessed with a complete neuropsychological battery focused on different domains such as executive function, memory, and attention.
Motor functions
时间窗: Immediately after the training experience
Improvement in motor functioning assessed with specific test focused on balance, functional mobility, and walking speed
次要结局
未报告次要终点