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)

January 19, 2021 updated by: University Hospital, Rouen

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

Not yet recruiting

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

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Rouen, France, 760031
        • Rouen University Hospital
        • Contact:
          • Marie-Laure WELTER, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
usual re-education treatment by their physiotherapist
Other Names:
  • Routine care
No Intervention: routine care
Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist.

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
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 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).
Through study completion, an average of 24 months
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
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
Time Frame: Through study completion, an average of 24 months
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
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.
Through study completion, an average of 24 months
The budgetary impact of Toap Run
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System).
Through study completion, an average of 24 months
Overall functioning
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD).
Through study completion, an average of 24 months
Emotional state
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
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
Time Frame: Through study completion, an average of 24 months
Patient and caregiver satisfaction will be assessed through a satisfaction survey.
Through study completion, an average of 24 months
Physician user satisfaction
Time Frame: Through study completion, an average of 24 months
Physician user satisfaction will be assessed through a satisfaction survey.
Through study completion, an average of 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Marie-Laure WELTER, Professor, Rouen Uiniversity Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2021

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

February 1, 2025

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

January 19, 2021

First Posted (Actual)

January 22, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 19, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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