On-line Cognitive Training for Mild Cognitive Impairment in Parkinson's Disease: a Randomized Single-blind Study Using Wearing Sensors Technology
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Trial making B performance, total score (0-240 seconds)
研究概览
简要总结
Application of online cognitive training in patients affected by Parkinson's disease and mild cognitive impairment. The treatment consists of a 6-week on-line cognitive training preceded and followed by neurological, neuropsychological and motor assessment.
详细描述
At the recruitment, participants will undergo a neurological visit, a neuropsychology assessment (2 tests for each considered cognitive domain: memory, attention, visuospatial, executive function, language) and a motor assessment with wearing sensors under supervised conditions.
In the treatment arm only, patients will have the Neuronation application installed on their personal technology device (smartphone or tablet) and are asked to complete 4 training session three times a week. Each session is composed of 5 exercises from one out of 4 cognitive domains: Memory, Attention, Speed and Reasoning. The training is tailor made, the complexity of the exercises is adjusted online, based on the patient's performance.
Participants are re-assessed at the end of the 6-week cognitive training (T1) to find out its effects on cognition and motor ability. The same assessment is administered also after 1 (T2) and 3 (T3) months from the end of the cognitive training to test long-term effects.
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)
盲法说明
The cognitive, motor and wearing sensors assessment will be performed by investigators blind to the treatment performed
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ease of use of at home internet connection
- •Active presence of a caregiver to help with the use of the App
- •Sufficient physical ability to use a technological device
- •Signature of informed consent
排除标准
- •Presence of systemic pathologies potentially responsible for cognitive deficits
- •Presence of pathologies of the Central Nervous system potentially associated with cognitive deficits
- •No access to internet connection
- •Cognitive rehabilitation within the previous 6 months
- •Major depression (assessed by Beck Depression Inventory at baseline)
结局指标
主要结局
Trial making B performance, total score (0-240 seconds)
时间窗: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Trial making B performance, total score (0-240 seconds)
Parkinson´s disease Quality of life questionnire (PDQ-39) (0-117 points)
时间窗: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
PDQ-39 will be assessed in patients
Supervised gait performance dual task gait
时间窗: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Step variability using wearing sensors technology in one-minute supervised dual task walking
Sum of total Z-score of cognitive assessment (-30 to 30)
时间窗: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Sum of total Z-score of cognitive assessment (-30 to 30)
Supervised gait performance normal gait
时间窗: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Step variability using wearing sensors technology in one-minute supervised walking
Quality of life - caregivers
时间窗: Changes between baseline, immediately after the end of intervention, after 1 month and 3 months
Caregiver Burden will be assessed with Dyadic relationship scale
次要结局
- Unified parkinson´s disease Rating Scale part 3 (0-132 points)(Changes between baseline, immediately after the end of intervention, after 1 month and 3 monthss)
- Instability measures(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
- Turning performances(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
- Dual task performance in circular walking (0-240 seconds)(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
- Short Physical performance battery (SPPB), total time (0- 60 seconds)(Changes between baseline, immediately after the end of intervention, after 1 month and 3 months)
研究者
Andrea Pilotto
Neurology Department Director
Università degli Studi di Brescia