Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games
研究概览
简要总结
This is a multi-center, randomized, open-label, multi-center, randomized controlled study of 80 Parkinson's disease patients with gait and balance disorders in which 40 patients will be treated with serious games, in addition to their usual care, for 12 months and 40 patients will be treated with their usual care during this period. This study will be conducted in 4 centers, all of which are expert in the management of these patients.
After randomization, each patient in the "Intervention-Rehabilitation through Toap Run" group will have to complete 2 to 3 sessions per week at home with the serious game "TOAP RUN" using the Kinect® system for 1 year.
详细描述
This is a multi-center, randomized, open-label, multi-center, randomized controlled study of 80 Parkinson's disease patients with gait and balance disorders in which 40 patients will be treated with serious games, in addition to their usual care, for 12 months and 40 patients will be treated with their usual care during this period. This study will be conducted in 4 centers, all of which are expert in the management of these patients.
After randomization, each patient in the "Intervention-Rehabilitation through Toap Run" group will have to complete 2 to 3 sessions per week at home with the serious game "TOAP RUN" using the Kinect® system for 1 year.
The primary endpoint is a medical-economic endpoint: the difference in incremental cost-utility ratio at 12 months between the 2 groups of patients. Costs will be assessed at inclusion, at the end of 6 and 12 months. Secondary endpoints include clinical and neurophysiological assessments, focusing on gait and balance disorders, as well as cognition and emotional state. An imaging study for patients included in the Paris-ICM center is also planned to study the effects of serious game rehabilitation on brain function.
Patients in both groups will be free to use SG at the end of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 idiopathic Parkinson's disease (according to United Kingdom Parkinson's Disease Society Brain Bank [UKPDD] criteria) ;
- •Age ≥ 18 years ;
- •Patient with gait and/or balance disorders not improved by levodopa treatment with item 12 "walking and balance" ≥ 1 of the MDS-UPDRS (Movement-Disorders Society-Unified Parkinson's disease rating scale) part II, ON levodopa and/or item 13 of "gait freezing" ≥ 1 (Goetz, Tilley et al. 2008);
- •Number of falls ≥ 2 in the previous year;
- •Stable antiparkinsonian treatments for at least 1 month prior to inclusion in the study ;
- •Patient with social health insurance ;
- •Person who voluntarily and informedly agreed to participate in the study (signed written consent) ;
- •Other medical problems that are stable or do not interfere with the proposed protocol;
排除标准
- •Parkinson's disease with Hoehn&Yahr stage 5 corresponding to an inability of the subject to stand or walk alone ;
- •Dementia (MMS < 24 and/or MoCA < 18) ;
- •Presence of an impulse control disorder defined by item 6 of the MDS-UPDRS part I > 2 ;
- •Absence of internet connection at home ;
- •Serious pathology interfering with the test ;
- •Estimated life expectancy of less than 2 years ;
- •Subject in a period of exclusion from further research ;
- •Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty ;
- •Pregnant woman or woman of childbearing age without contraceptive methods;
研究组 & 干预措施
play-based rehabilitation
Patients randomized in the "play-based rehabilitation" group will perform 2 to 3 gambling rehabilitation sessions at home using the Kinect® system linked to the Curapy.com platform for 12 months.
干预措施: play-based rehabilitaion (Device)
routine care
Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.
结局指标
主要结局
The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games
时间窗: at 12 months for the management of patients with Parkinson's disease using therapeutic games
The result criterion is the additional cost in euros of a QALY gained. The QALY will be calculated from the utilities derived from the EuroQuality scale of life-5 dimensions EQ5D-3L.
次要结局
- The level of physical activity(Through study completion, an average of 24 months)
- The frequency of falls(Through study completion, an average of 24 months)
- Cost-effectiveness ratio of falls prevention(Through study completion, an average of 24 months)
- The budgetary impact of Toap Run(Through study completion, an average of 24 months)
- Patient and caregiver satisfaction(Through study completion, an average of 24 months)
- Physician user satisfaction(Through study completion, an average of 24 months)
- The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management.(Through study completion, an average of 24 months)
- Incidence of treatment on Motor skills(Through study completion, an average of 24 months)
- Incidence of treatment on Neurological motor skills(Through study completion, an average of 24 months)
- Incidence of treatment on Patients' quality of life(Through study completion, an average of 24 months)
- Mood and anxiety(Through study completion, an average of 24 months)
- Criterion for the cost-utility ratio(Through study completion, an average of 24 months)
- Overall functioning(Through study completion, an average of 24 months)
- Evaluation of usability and feasibility of SGs(Through study completion, an average of 24 months)
- Emotional state(Through study completion, an average of 24 months)