Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders

Patients With Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04720365
• Other study ID #: 2019/0238/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: December 2020
• Source: University Hospital, Rouen
• Contact: Nell Marty
• Phone: (33) 02 32 88 82 65
• Email: Nell.Marty[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Parkinson Disease
• Patients With Parkinson's Disease

Intervention

Device:
• play-based rehabilitaion
usual re-education treatment by their physiotherapist

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Incidence of treatment on Neurological motor skills	Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System).	Through study completion, an average of 24 months
Secondary	Overall functioning	Overall functioning will be assessed by the Global Functioning Scale (GFS).	Through study completion, an average of 24 months
Secondary	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
Secondary	Mood and anxiety	Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD).	Through study completion, an average of 24 months
Secondary	Emotional state	Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS).	Through study completion, an average of 24 months
Secondary	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
Secondary	Patient and caregiver satisfaction	Patient and caregiver satisfaction will be assessed through a satisfaction survey.	Through study completion, an average of 24 months
Secondary	Physician user satisfaction	Physician user satisfaction will be assessed through a satisfaction survey.	Through study completion, an average of 24 months