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New treatment option for Patients With Parkinson's Disease
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
ClinicalTrials.gov ID: NCT04720365
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Number of falls ≥ 2 in the previous year;
- Stable antiparkinsonian treatments for at least 1 month prior to inclusion in the study ;
You likely can't join if
- 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 ;
See the full eligibility 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...
- 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;
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lille, France
- Paris, France
- Rouen, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lille, France; Paris, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.