Development and Validation of a Smart Phone Based System to Enhance Gait, Cognition and Socialization in Elderly Fallers
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 主要终点
- Change in average number of steps per day
研究概览
简要总结
The main objective of this research is to develop and validate a technology-based solution that addresses the diminished mobility, increased fall risk and impaired cognitive function that are so common among older adults, enabling them to live longer successfully and independently.
详细描述
A comprehensive system will be developed to promote mobility, enhance cognitive function, reduce sedentary behavior, increase independence and encourage social inclusion. This novel system will have two distinct yet complementary features: monitoring and treatment that will serve as an "all in one system". The system will consist of wearable sensors and a proprietary developed application. The wearable inertial sensors will measure the acceleration and orientation of the feet during movement. The sensors will feed real-time data to the system, which will process this data using a set of proprietary algorithms enabling continuous monitoring of activity, gait and fall risk, and independence. In addition, designated applications for direct cognitive assessment and training of older adults in their home and community environment will also be used via the Smart phone or mobile tablet. The training, both physical and cognitive, will also include multi-user interactions .Data collected by the system will be processed and integrated to provide comprehensive feedback from multiple domains to the user, caregiver and clinician by way of recommendations and personalized treatment goals.
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 (Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages of 65-85 years
- •History of 1 fall or more in the year prior to the study.
排除标准
- •Signs of dementia : Montreal Cognitive Assessment (MoCa) <21 and/or mini mental state examination(MMSE) <
- •Psychiatric co-morbidities :major depression as determined by Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria
- •Co-existing somatic disorders
- •History of stroke
- •Neurologic disorders that interferes with normal walking (e.g., Parkinson's disease or Alzheimer's disease),
- •Cannot walk without assistance,
- •Severe head trauma or brain tumor,
- •Severe hearing or visual loss (determined by the visual acuity test),
- •Cardio-vascular contradictions (as determined by a physician),
- •Inability to use a Smart phone because of visual and manual impairment or have unstable medical conditions.
结局指标
主要结局
Change in average number of steps per day
时间窗: Number of steps will be measured during one week after each assessment - at baseline, immediately after the training and 3 months after the training.
This will be evaluated by a small, lightweight waterproof accelerometer placed on the lower back of the participants (Axivity Ltd.)
Changes in the color Trails Making Test part B
时间窗: At baseline, immediately after the training and 3 months after completing the training.
次要结局
- Changes in gait speed(At baseline, immediately after the training and 3 months after completing the training.)
- Changes in fear of falling(At baseline, immediately after the training and 3 months after completing the training)
- Changes in endurance(At baseline, immediately after the training and 3 months after completing the training)
- Changes in social connectedness(At baseline, immediately after the training and 3 months after completing the training)
- Changes in cognitive function: score in Frontal Assessment Battery(At baseline, immediately after the training and 3 months after completing the training)
- Changes in functional mobility: dynamic gait index (DGI) score(At baseline, immediately after the training and 3 months after completing the training)
- Changes in the Short Form Health Survey(At baseline, immediately after the training and 3 months after completing the training)
- Changes in stride length(At baseline, immediately after the training and 3 months after completing the training.)
- Changes in stride and swing time variability(At baseline, immediately after the training and 3 months after completing the training.)
- Changes in cognitive function: number of digits(At baseline, immediately after the training and 3 months after completing the training)
- Changes in cognitive function: number of correct / incorrect answers(At baseline, immediately after the training and 3 months after completing the training)
- Changes in functional mobility: score in Four Square Step Test(At baseline, immediately after the training and 3 months after completing the training)