Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство play-based rehabilitaion
  usual re-education treatment by their physiotherapist

Первичные конечные точки

• The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games [Срок оценки: at 12 months for the management of patients with Parkinson's disease using therapeutic games]

Вторичные конечные точки (12)

• The frequency of falls [Срок оценки: Through study completion, an average of 24 months]
• The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management. [Срок оценки: Through study completion, an average of 24 months]
• Cost-effectiveness ratio of falls prevention [Срок оценки: Through study completion, an average of 24 months]
• Criterion for the cost-utility ratio [Срок оценки: Through study completion, an average of 24 months]
• The budgetary impact of Toap Run [Срок оценки: Through study completion, an average of 24 months]
• Incidence of treatment on Patients' quality of life [Срок оценки: Through study completion, an average of 24 months]
• Incidence of treatment on Motor skills [Срок оценки: Through study completion, an average of 24 months]
• Incidence of treatment on Neurological motor skills [Срок оценки: Through study completion, an average of 24 months]
• Overall functioning [Срок оценки: Through study completion, an average of 24 months]
• Evaluation of usability and feasibility of SGs [Срок оценки: Through study completion, an average of 24 months]
• Mood and anxiety [Срок оценки: Through study completion, an average of 24 months]
• Emotional state [Срок оценки: Through study completion, an average of 24 months]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 4 центра

• Chu Bordeaux — Bordeaux
• Chu Lille — Lille
• Gh Pitie Salpetriere — Paris
• Rouen University Hospital — Rouen

Идентификаторы

NCT: NCT04720365 · 2019/0238/HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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