Clinical trial NCT04720365: Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
Official title: Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Parkinson's Disease
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental, prospective, controlled, open randomized, multicenter, national research.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of idiopathic Parkinson's disease (according to United Kingdom Parkinson's Disease Society Brain Bank \[UKPDD\] criteria) ;
2. Age ≥ 18 years ;
3. 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);
4. Number of falls ≥ 2 in the previous year;
5. Stable antiparkinsonian treatments for at least 1 month prior to inclusion in the study ;
6. Patient with social health insurance ;
7. Person who voluntarily and informedly agreed to participate in the study (signed written consent) ;
8. Other medical problems that are stable or do not interfere with the proposed protocol;

Exclusion Criteria:

1. Parkinson's disease with Hoehn\&Yahr stage 5 corresponding to an inability of the subject to stand or walk alone ;
2. Dementia (MMS \< 24 and/or MoCA \< 18) ;
3. Presence of an impulse control disorder defined by item 6 of the MDS-UPDRS part I \> 2 ;
4. Absence of internet connection at home ;
5. Serious pathology interfering with the test ;
6. Estimated life expectancy of less than 2 years ;
7. Subject in a period of exclusion from further research ;
8. Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and liberty ;
9. Pregnant woman or woman of childbearing age without contraceptive methods;

Primary outcomes:
measure: The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games
timeFrame: at 12 months for the management of patients with Parkinson's disease using therapeutic games
Secondary outcomes:
measure: The frequency of falls
timeFrame: Through study completion, an average of 24 months
measure: The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management.
timeFrame: Through study completion, an average of 24 months
measure: Cost-effectiveness ratio of falls prevention
timeFrame: Through study completion, an average of 24 months
measure: Criterion for the cost-utility ratio
timeFrame: Through study completion, an average of 24 months
measure: The budgetary impact of Toap Run
timeFrame: Through study completion, an average of 24 months
measure: Incidence of treatment on Patients' quality of life
timeFrame: Through study completion, an average of 24 months
measure: Incidence of treatment on Motor skills
timeFrame: Through study completion, an average of 24 months
measure: Incidence of treatment on Neurological motor skills
timeFrame: Through study completion, an average of 24 months
measure: Overall functioning
timeFrame: Through study completion, an average of 24 months
measure: Evaluation of usability and feasibility of SGs
timeFrame: Through study completion, an average of 24 months
measure: Mood and anxiety
timeFrame: Through study completion, an average of 24 months
measure: Emotional state
timeFrame: Through study completion, an average of 24 months
measure: The level of physical activity
timeFrame: Through study completion, an average of 24 months
measure: Patient and caregiver satisfaction
timeFrame: Through study completion, an average of 24 months
measure: Physician user satisfaction
timeFrame: Through study completion, an average of 24 months
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: Rouen Uiniversity Hospital
name: Marie-Laure WELTER, Professor
role: PRINCIPAL_INVESTIGATOR
References: