Patients With Parkinson's Disease
Conditions
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.
Interventions
DEVICEplay-based rehabilitaion
usual re-education treatment by their physiotherapist
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Experimental, prospective, controlled, open randomized, multicenter, national research.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The frequency of falls | Through study completion, an average of 24 months | The frequency of falls will be measured using item 12 of the Freezing of gait questionnaire (FOG-Q), with falls being absent (score=0), very rare (about 1/year, score=1), rare (about 1/ month, score=2), frequent (about 1/week, score=3) or very frequent (every day or several falls per day, score=4). |
| The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management. | Through study completion, an average of 24 months | The outcome criterion will be measured by the number of days of hospitalization at 12 and 24 months. |
| Cost-effectiveness ratio of falls prevention | Through study completion, an average of 24 months | For the cost-effectiveness ratio of falls prevention, the clinical outcome criterion will be measured by the number of falls at 12 and 24 months. |
| Criterion for the cost-utility ratio | Through study completion, an average of 24 months | The criterion for the cost-utility ratio at 24 months will be the QALY calculated from the utilities derived from the EuroQuality scale of life-5 dimensions EQ5D-3L. |
| The budgetary impact of Toap Run | Through study completion, an average of 24 months | The budgetary impact of Toap Run in the management of Parkinson's patients will be measured by the resources directly consumed using the SNIIRAM/SNDS database (order of March 22, 2017 of the Public Health Code). |
| Incidence of treatment on Patients' quality of life | Through study completion, an average of 24 months | Patients' quality of life will be assessed using the PDQ-39 scale, which is specific to Parkinson's disease. |
| Incidence of treatment on Motor skills | Through study completion, an average of 24 months | Motor skills (walking and balance) will be assessed using clinically validated scales (UPDRS, Gait and Balance Scale, Freezing-of-gait questionnaire, Fear of falling) |
| Incidence of treatment on Neurological motor skills | Through study completion, an average of 24 months | Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System). |
| Overall functioning | Through study completion, an average of 24 months | Overall functioning will be assessed by the Global Functioning Scale (GFS). |
| Evaluation of usability and feasibility of SGs | Through study completion, an average of 24 months | The usability and feasibility of SGs will be assessed through by patients' usability and feasability questionnaire. |
| Mood and anxiety | Through study completion, an average of 24 months | Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD). |
| Emotional state | Through study completion, an average of 24 months | Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS). |
| The level of physical activity | Through study completion, an average of 24 months | The level of physical activity evaluated with the International Physical Activity Questionnaire (IPAQ). |
| Patient and caregiver satisfaction | Through study completion, an average of 24 months | Patient and caregiver satisfaction will be assessed through a satisfaction survey. |
| Physician user satisfaction | Through study completion, an average of 24 months | Physician user satisfaction will be assessed through a satisfaction survey. |
Countries
France
Contacts
CONTACTNell Marty
PRINCIPAL_INVESTIGATORMarie-Laure WELTER, Professor
Rouen Uiniversity Hospital
Outcome results
None listed