The Effectiveness of Mixed Reality as Interventional Tool for the Improvement on Quality of Life for People With Parkinson´s Disease. Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- EuroQol 5 Dimension 5 Level
研究概览
简要总结
Parkinson's disease is a chronic, neurodegenerative disease of unknown cause, affecting elderly people over the age of 60. It is the second most common neurodegenerative disease, presenting psychomotor signs and symptoms that lead to impaired functionality and quality of life in affected individuals. Mixed reality involves the delivery of digital stimuli in real time and space through spatial mapping using glasses, safely providing multiple iterations to carry out daily activities.
Through this tool and in collaboration with technologically skilled mixed reality developers, the software for the rehabilitation program to be applied to Parkinson's disease patients was also developed.
The main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation of people with Parkinson's disease.
详细描述
Parkinson's disease is a chronic, neurodegenerative disease of unknown cause, affecting elderly people over the age of 60. It is the second most common neurodegenerative disease, presenting psychomotor signs and symptoms that lead to impaired functioning and quality of life in affected individuals. Mixed reality involves the delivery of digital stimuli in real time and space through spatial mapping using glasses, safely providing multiple iterations to carry out daily activities.
Through this tool and in collaboration with technologically skilled mixed reality developers, the software for the rehabilitation program to be applied to Parkinson's disease patients was also developed.
The main objective of this clinical study is to examine the effect of a mixed reality program compared to a traditional physiotherapy program on quality of life and motivation for the participation for people with Parkinson's disease.
The study will be divided into two phases, the first of which includes the translation and adaptation of the Intrinsic Motivation Inventory (IMI) questionnaire, which assesses motivation and is not available in Greek, and will be used in 300 healthy subjects to assess its psychometric characteristics.
The second phase of the clinical trial is a parallel, blinded, randomized study involving 45 patients.
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
- None
入排标准
- 年龄范围
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female over 18 years old
- •Persons with independent gait
- •Normal cognitive ability
- •Greek Native language
排除标准
- •Presence of neurological disease
- •Presence of uncontrolled diseases of the circulatory system
- •History of musculoskeletal surgery in the last 6 months
- •Use of a walking aid
- •Partial or total blindness
- •For the second interventional phase:
- •Inclusion Criteria:
- •Male and female over 60 years old
- •Persons with independent gait
- •Normal cognitive ability
- •Greek Native language
- •Exclusion Criteria:
- •Presence of neurological disease
- •Presence of uncontrolled diseases of the circulatory system
- •History of musculoskeletal surgery in the last 6 months
- •Use of a walking aid
- •Partial or total blindness
结局指标
主要结局
EuroQol 5 Dimension 5 Level
时间窗: baseline, 4weeks follow up
Measurement of quality of life. Likert scoring style (1-5) where higher scores represent worse state of quality of life
The Short Form (12) Health Survey
时间窗: baseline, 4weeks follow up
Measurement of quality of life: The scores ranged from 0 to 100, where higher scores representing better quality of life
次要结局
- Multidirectional Reach Test(baseline, 4weeks follow up)
- Nine-Hole Peg Test(baseline, 4weeks follow up)
- Intrinsic Motivation Inventory(baseline, 4weeks follow up)
- Mini Balance Evaluation Systems Test(baseline, 4weeks follow up)
研究者
Elena Papamichael
PhD Candidate in Physiotherapy
University of Nicosia