Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 KinectĀ® system for 1 year.
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 KinectĀ® 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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| play-based rehabilitation | Experimental | Patients randomized in the "play-based rehabilitation" group will perform 2 to 3 gambling rehabilitation sessions at home using the KinectĀ® system linked to the Curapy.com platform for 12 months. |
|
| routine care | No Intervention | Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| play-based rehabilitaion | Device | usual re-education treatment by their physiotherapist |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incremental cost-utility ratio 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. | at 12 months for the management of patients with Parkinson's disease using therapeutic games |
| Measure | Description | Time Frame |
|---|---|---|
| The frequency of falls | 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). | Through study completion, an average of 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nell Marty | Contact | (33) 02 32 88 82 65 | Nell.Marty@chu-rouen.fr |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Laure WELTER, Professor | Rouen Uiniversity Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Bordeaux | Recruiting | Bordeaux | 33076 | France |
Not provided
Experimental, prospective, controlled, open randomized, multicenter, national research.
Not provided
Not provided
Not provided
Not provided
| The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management. | The outcome criterion will be measured by the number of days of hospitalization at 12 and 24 months. | Through study completion, an average of 24 months |
| Cost-effectiveness ratio of falls prevention | 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. | Through study completion, an average of 24 months |
| Criterion for the cost-utility ratio | 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. | Through study completion, an average of 24 months |
| The budgetary impact of Toap Run | 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). | Through study completion, an average of 24 months |
| Incidence of treatment on Patients' quality of life | Patients' quality of life will be assessed using the PDQ-39 scale, which is specific to Parkinson's disease. | Through study completion, an average of 24 months |
| Incidence of treatment on Motor skills | Motor skills (walking and balance) will be assessed using clinically validated scales (UPDRS, Gait and Balance Scale, Freezing-of-gait questionnaire, Fear of falling) | Through study completion, an average of 24 months |
| Incidence of treatment on Neurological motor skills | Neurological motor skills will be assessed using a neurophysiological evaluation (VICONĀ® System). | Through study completion, an average of 24 months |
| Overall functioning | Overall functioning will be assessed by the Global Functioning Scale (GFS). | Through study completion, an average of 24 months |
| Evaluation of usability and feasibility of SGs | The usability and feasibility of SGs will be assessed through by patients' usability and feasability questionnaire. | Through study completion, an average of 24 months |
| Mood and anxiety | Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD). | Through study completion, an average of 24 months |
| Emotional state | Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS). | Through study completion, an average of 24 months |
| The level of physical activity | The level of physical activity evaluated with the International Physical Activity Questionnaire (IPAQ). | Through study completion, an average of 24 months |
| Patient and caregiver satisfaction | Patient and caregiver satisfaction will be assessed through a satisfaction survey. | Through study completion, an average of 24 months |
| Physician user satisfaction | Physician user satisfaction will be assessed through a satisfaction survey. | Through study completion, an average of 24 months |
| Chu Lille | Recruiting | Lille | 59037 | France |
|
| Gh Pitie Salpetriere | Recruiting | Paris | 75013 | France |
|
| Rouen University Hospital | Recruiting | Rouen | 76031 | France |
|