- ICH GCP
- US Clinical Trials Registry
- 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 (PARKGAME_ECO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nell Marty
- Phone Number: (33) 02 32 88 82 65
- Email: Nell.Marty@chu-rouen.fr
Study Locations
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Rouen, France, 760031
- Rouen University Hospital
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Contact:
- Marie-Laure WELTER, Professor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: play-based rehabilitation
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.
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usual re-education treatment by their physiotherapist
Other Names:
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No Intervention: routine care
Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incremental cost-utility ratio at 12 months for the management of patients with Parkinson's disease using therapeutic games
Time Frame: at 12 months for the management of patients with Parkinson's disease using therapeutic games
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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.
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at 12 months for the management of patients with Parkinson's disease using therapeutic games
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The frequency of falls
Time Frame: 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).
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Through study completion, an average of 24 months
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The incremental cost-effectiveness ratio of Toap Run therapeutic gambling management compared to usual management.
Time Frame: Through study completion, an average of 24 months
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The outcome criterion will be measured by the number of days of hospitalization at 12 and 24 months.
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Through study completion, an average of 24 months
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Cost-effectiveness ratio of falls prevention
Time Frame: Through study completion, an average of 24 months
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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.
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Through study completion, an average of 24 months
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Criterion for the cost-utility ratio
Time Frame: 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.
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Through study completion, an average of 24 months
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The budgetary impact of Toap Run
Time Frame: Through study completion, an average of 24 months
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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).
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Through study completion, an average of 24 months
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Incidence of treatment on Patients' quality of life
Time Frame: Through study completion, an average of 24 months
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Patients' quality of life will be assessed using the PDQ-39 scale, which is specific to Parkinson's disease.
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Through study completion, an average of 24 months
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Incidence of treatment on Motor skills
Time Frame: Through study completion, an average of 24 months
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Motor skills (walking and balance) will be assessed using clinically validated scales (UPDRS, Gait and Balance Scale, Freezing-of-gait questionnaire, Fear of falling)
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Through study completion, an average of 24 months
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Incidence of treatment on Neurological motor skills
Time Frame: Through study completion, an average of 24 months
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Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System).
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Through study completion, an average of 24 months
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Overall functioning
Time Frame: Through study completion, an average of 24 months
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Overall functioning will be assessed by the Global Functioning Scale (GFS).
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Through study completion, an average of 24 months
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Evaluation of usability and feasibility of SGs
Time Frame: Through study completion, an average of 24 months
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The usability and feasibility of SGs will be assessed through by patients' usability and feasability questionnaire.
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Through study completion, an average of 24 months
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Mood and anxiety
Time Frame: Through study completion, an average of 24 months
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Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD).
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Through study completion, an average of 24 months
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Emotional state
Time Frame: Through study completion, an average of 24 months
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Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS).
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Through study completion, an average of 24 months
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The level of physical activity
Time Frame: Through study completion, an average of 24 months
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The level of physical activity evaluated with the International Physical Activity Questionnaire (IPAQ).
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Through study completion, an average of 24 months
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Patient and caregiver satisfaction
Time Frame: Through study completion, an average of 24 months
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Patient and caregiver satisfaction will be assessed through a satisfaction survey.
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Through study completion, an average of 24 months
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Physician user satisfaction
Time Frame: Through study completion, an average of 24 months
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Physician user satisfaction will be assessed through a satisfaction survey.
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Through study completion, an average of 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marie-Laure WELTER, Professor, Rouen Uiniversity Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019/0238/HP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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