Serious Games for Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
IMPORTANCE: Rehabilitation games have been shown to improve cognitive function among people with various disorders but they have not been explored in home settings for patients with Parkinson's disease.
OBJECTIVE: To collect pilot data regarding the therapeutic benefits of self-administered rehabilitation games among patients with Parkinson's disease.
METHODS: The investigators will recruit 20 patients with Parkinson's disease into a pilot randomized controlled trial. Patients will be asked to perform two 30-minute sessions per week of training using serious games over a 3-month period in addition to conventional care or undergo only usual care. Patients will be evaluated at baseline, after 12 weeks of treatment, and at 24 weeks. Improvements in cognitive function, depression, quality of life, and mobility will be assessed.
RELEVANCE: Identifying whether self-administered rehabilitation games can lead to clinical improvements could have significant implications for the management of the disease.
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)
盲法说明
Outcome assessors will be blinded to participant assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of mild to moderate PD (Hoehn & Yahr 1-3)
- •baseline MoCA score <26
- •≥ 18 years-old
- •ability to communicate and read in English
- •have self-reported technological literacy (ie answer yes to the question asking if they are comfortable using technological devices)
排除标准
- •comorbid conditions that could affect the performance of the tasks (e.g. severe uncorrected vision impairment)
- •severe cognitive impairment that would prevent the patient from understanding the tasks (MoCA<16)
- •if the subject does not want to be video recorded during the assessments or interview sessions
- •if the subject does not have access to WiFi
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: Follow-up (week 24)
The Montreal Cognitive Assessment is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The minimum score is 0 the maximum score is 30. Higher scores indicate higher cognitive function and lower scores indicate lower cognitive function.
次要结局
- PDQ-39(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
- Digit span forward and backward(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
- LifeSpace Assessment(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
- Semantic fluency test(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
- Geriatric depression scale(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
- Sensor-based mobility(Baseline (week 0), Post-intervention (week 12), Follow-up (week 24))
研究者
Jean-Francois Daneault, Ph.D.
Assistant professor
Rutgers, The State University of New Jersey