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

NCT ID: NCT04720365

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-02-01

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.

Conditions

Patients With Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

play-based rehabilitaion

Intervention Type: DEVICE

usual re-education treatment by their physiotherapist

routine care

Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

play-based rehabilitaion

usual re-education treatment by their physiotherapist

Intervention Type: DEVICE

Other Intervention Names

Routine care

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Laure WELTER, Professor

Role: PRINCIPAL_INVESTIGATOR

Rouen Uiniversity Hospital

Locations

Rouen University Hospital

Rouen, , France

Countries

France

Central Contacts

Nell Marty

Role: CONTACT

Nell.Marty@chu-rouen.fr

(33) 02 32 88 82 65

Facility Contacts

Marie-Laure WELTER, Professor

Role: primary

Other Identifiers

2019/0238/HP

Identifier Type: -

Identifier Source: org_study_id