Patients With Parkinson's DiseasePARKGAME_ECONCT04720365
Medico-economic Evaluation Rehabilitation by Serious Games at Home for the Management of Patients With Parkinson's Disease Suffering From Gait and Balance Disorders
A study testing play-based rehabilitaion in people with Patients With Parkinson's Disease, run by University Hospital, Rouen at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Parkinson's Disease
- What is being tested?
- play-based rehabilitaion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesFrance
- Study dates
- 15 Feb 2023to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 levodopa and/or item 13 of "gait freezing" ≥ 1 (Goetz, Tilley et al. 2008);
- 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;
Who cannot join
- 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 ;
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- 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;
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Chu Bordeaux
Bordeaux, 33076
Dominique Guehl, Pr, 05 57 57 15 51, dominique.guehl@ubordeaux2.fr
Dominique Guehl, Pr
- Recruiting
Chu Lille
Lille, 59037
Caroline Moreau, Pr, 03 20 44 59 62, caroline.moreau@chru-lille.fr
Caroline Moreau, Pr
- Recruiting
Gh Pitie Salpetriere
Paris, 75013
Louise Laure Mariani, Dr, 01 42 17 62 05, louiselaure.mariani@aphp.fr
Louise Laure Mariani, Dr
- Recruiting
Rouen University Hospital
Rouen, 76031
Marie-Laure WELTER, Professor, 02 32 88 80 37, Marie-Laure.Welter@chu-rouen.fr
Marie-Laure Welter, Pr
About this study
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.
Read the 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
- Being tested
- play-based rehabilitaion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
play-based rehabilitaionDevice
Also called Routine care
usual re-education treatment by their physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| play-based rehabilitation | Experimental | 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. Receives: Device: play-based rehabilitaion |
| routine care | No intervention | Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 12 months for the management of patients with Parkinson's disease using therapeutic games
Secondary outcomes (15)
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).
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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).
Measured: Through study completion, an average of 24 months
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.
Measured: Through study completion, an average of 24 months
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)
Measured: Through study completion, an average of 24 months
Incidence of treatment on Neurological motor skills
Neurological motor skills will be assessed using a neurophysiological evaluation (VICON® System).
Measured: Through study completion, an average of 24 months
Overall functioning
Overall functioning will be assessed by the Global Functioning Scale (GFS).
Measured: Through study completion, an average of 24 months
Evaluation of usability and feasibility of SGs
The usability and feasibility of SGs will be assessed through by patients' usability and feasability questionnaire.
Measured: Through study completion, an average of 24 months
Mood and anxiety
Mood and anxiety will be assessed with the Hospital Anxiety Depression scale (HAD).
Measured: Through study completion, an average of 24 months
Emotional state
Emotional state will be assessed with the Positive Affect Negative Affect Scale (PANAS).
Measured: Through study completion, an average of 24 months
The level of physical activity
The level of physical activity evaluated with the International Physical Activity Questionnaire (IPAQ).
Measured: Through study completion, an average of 24 months
Patient and caregiver satisfaction
Patient and caregiver satisfaction will be assessed through a satisfaction survey.
Measured: Through study completion, an average of 24 months
Physician user satisfaction
Physician user satisfaction will be assessed through a satisfaction survey.
Measured: Through study completion, an average of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start15 Feb 2023
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental, prospective, controlled, open randomized, multicenter, national research.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Laure WELTER, Professor, Principal investigator, Rouen Uiniversity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720365
- Sponsor's protocol ID
- 2019/0238/HP
- Acronym
- PARKGAME_ECO
- Status last verified
- Feb 2026
- First submitted
- 29 Dec 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- PARKGAME_ECO / 2019/0238/HP
- Conditions
- Patients With Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental, prospective, controlled, open randomized, multicenter, national research.
| Arm | Type | Receives |
|---|---|---|
| play-based rehabilitation | Experimental | Device: play-based rehabilitaionPatients 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. |
| routine care | No intervention | –Patients randomized in the "usual care" group will have their usual rehabilitation care provided by their physiotherapist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 levodopa and/or item 13 of "gait freezing" ≥ 1 (Goetz, Tilley et al. 2008);
- Number of falls ≥ 2 in the previous year;
- Stable antiparkinsonian treatments for at least 1 month prior to inclusion in the study ;
Key exclusion criteria (9 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| play-based rehabilitaionAlso: Routine careusual re-education treatment by their physiotherapist | Device | play-based rehabilitation |
Primary outcome
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.
15 secondary outcomes
The frequency of falls
Time frame: 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
Cost-effectiveness ratio of falls prevention
Time frame: 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 budgetary impact of Toap Run
Time frame: 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
Incidence of treatment on Motor skills
Time frame: 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
Overall functioning
Time frame: 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
Mood and anxiety
Time frame: Through study completion, an average of 24 months
Emotional state
Time frame: Through study completion, an average of 24 months
The level of physical activity
Time frame: Through study completion, an average of 24 months
Patient and caregiver satisfaction
Time frame: Through study completion, an average of 24 months
Physician user satisfaction
Time frame: Through study completion, an average of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Laure WELTER, Professor principal investigator
Rouen Uiniversity Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing play-based rehabilitaion in people with Patients With Parkinson's Disease, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nell Marty ((33) 02 32 88 82 65, Nell.Marty@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.