Back to resultsMedico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders (PARKGAME_ECO)
Primary Purpose
Patients With Parkinson's Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
play-based rehabilitaion
Sponsored by
About this trial
This is an interventional other trial for Patients With Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
play-based rehabilitation
routine care
Arm Description
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.
Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
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.
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.
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).
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.
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)
Incidence of treatment on Neurological motor skills
Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System).
Overall functioning
Overall functioning will be assessed by the Global Functioning Scale (GFS).
Evaluation of usability and feasibility of SGs
The usability and feasibility of SGs will be assessed through by patients' usability and feasability questionnaire.
Mood and anxiety
Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD).
Emotional state
Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS).
The level of physical activity
The level of physical activity evaluated with the International Physical Activity Questionnaire (IPAQ).
Patient and caregiver satisfaction
Patient and caregiver satisfaction will be assessed through a satisfaction survey.
Physician user satisfaction
Physician user satisfaction will be assessed through a satisfaction survey.
Full Information
NCT ID
NCT04720365
First Posted
December 29, 2020
Last Updated
January 19, 2021
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT04720365
Brief 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
Acronym
PARKGAME_ECO
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2021 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Parkinson's Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental, prospective, controlled, open randomized, multicenter, national research.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
play-based rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
routine care
Arm Type
No Intervention
Arm Description
Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.
Intervention Type
Device
Intervention Name(s)
play-based rehabilitaion
Other Intervention Name(s)
Routine care
Intervention Description
usual re-education treatment by their physiotherapist
Primary Outcome Measure Information:
Title
The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games
Description
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.
Time Frame
at 12 months for the management of patients with Parkinson's disease using therapeutic games
Secondary Outcome Measure Information:
Title
The frequency of falls
Description
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).
Time Frame
Through study completion, an average of 24 months
Title
The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management.
Description
The outcome criterion will be measured by the number of days of hospitalization at 12 and 24 months.
Time Frame
Through study completion, an average of 24 months
Title
Cost-effectiveness ratio of falls prevention
Description
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.
Time Frame
Through study completion, an average of 24 months
Title
Criterion for the cost-utility ratio
Description
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.
Time Frame
Through study completion, an average of 24 months
Title
The budgetary impact of Toap Run
Description
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).
Time Frame
Through study completion, an average of 24 months
Title
Incidence of treatment on Patients' quality of life
Description
Patients' quality of life will be assessed using the PDQ-39 scale, which is specific to Parkinson's disease.
Time Frame
Through study completion, an average of 24 months
Title
Incidence of treatment on Motor skills
Description
Motor skills (walking and balance) will be assessed using clinically validated scales (UPDRS, Gait and Balance Scale, Freezing-of-gait questionnaire, Fear of falling)
Time Frame
Through study completion, an average of 24 months
Title
Incidence of treatment on Neurological motor skills
Description
Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System).
Time Frame
Through study completion, an average of 24 months
Title
Overall functioning
Description
Overall functioning will be assessed by the Global Functioning Scale (GFS).
Time Frame
Through study completion, an average of 24 months
Title
Evaluation of usability and feasibility of SGs
Description
The usability and feasibility of SGs will be assessed through by patients' usability and feasability questionnaire.
Time Frame
Through study completion, an average of 24 months
Title
Mood and anxiety
Description
Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD).
Time Frame
Through study completion, an average of 24 months
Title
Emotional state
Description
Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS).
Time Frame
Through study completion, an average of 24 months
Title
The level of physical activity
Description
The level of physical activity evaluated with the International Physical Activity Questionnaire (IPAQ).
Time Frame
Through study completion, an average of 24 months
Title
Patient and caregiver satisfaction
Description
Patient and caregiver satisfaction will be assessed through a satisfaction survey.
Time Frame
Through study completion, an average of 24 months
Title
Physician user satisfaction
Description
Physician user satisfaction will be assessed through a satisfaction survey.
Time Frame
Through study completion, an average of 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Exclusion Criteria:
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nell Marty
Phone
(33) 02 32 88 82 65
Email
Nell.Marty@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Laure WELTER, Professor
Organizational Affiliation
Rouen Uiniversity Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
760031
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure WELTER, Professor
12. IPD Sharing Statement
Learn more about this trial
Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
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