Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by University Hospital, Rouen · Updated on 2026-02-06

80

Participants Needed

4

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of idiopathic Parkinson's disease according to UKPDD criteria
  • Age 18 years or older
  • Presence of gait and/or balance disorders not improved by levodopa treatment with specific MDS-UPDRS scores
  • History of two or more falls in the previous year
  • Stable antiparkinsonian treatments for at least 1 month before joining the study
  • Patient has social health insurance
  • Voluntary agreement with signed written consent to participate
  • Other stable medical problems that do not interfere with the study protocol
Not Eligible

You will not qualify if you...

  • Parkinson's disease at Hoehn & Yahr stage 5 with inability to stand or walk alone
  • Dementia with MMS score less than 24 and/or MoCA score less than 18
  • Presence of impulse control disorder with MDS-UPDRS part I item 6 score greater than 2
  • No internet connection available at home
  • Serious illness interfering with the test
  • Life expectancy estimated to be less than 2 years
  • Currently excluded from other research studies
  • Under guardianship, curatorship, or legal deprivation of rights
  • Pregnant women or women of childbearing age not using contraceptive methods

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Chu Bordeaux

Bordeaux, France, 33076

Actively Recruiting

2

Chu Lille

Lille, France, 59037

Actively Recruiting

3

Gh Pitie Salpetriere

Paris, France, 75013

Actively Recruiting

4

Rouen University Hospital

Rouen, France, 76031

Actively Recruiting

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Research Team

N

Nell Marty

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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