Parkinson's DiseasePARKGAMENCT02469350
Serious Game for Parkinson's Disease Patients
A study testing Serious game in people with Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Serious game
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to 4 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease
- Gait and balance disorders
- Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year).
Who cannot join
- Dementia
- Ongoing severe medical condition that prevented assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.
- Conditions
- Parkinson's Disease
- Being tested
- Serious game
- Keywords
- Gait and balance disorders, serious game
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serious gameOther
Rehabilitation with serious game
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with serious game | Experimental | 18 rehabilitation sessions with serious game during a 6-8 weeks period Receives: Other: Serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility questionnaire
self-assessment questionnaire
Measured: once a week
Secondary outcomes (3)
Acceptability questionnaire
self-assessment questionnaire
Measured: once a week
biomechanical parameters of gait and balance
recordings of centres of foot and mass displacements and velocities
Measured: at inclusion, 3 weeks, 6 weeks and 18 weeks
kinematics parameters of gait and balance
range of motion of hip, knee and ankle angles
Measured: at inclusion, 3 weeks, 6 weeks and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion4 May 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marie-Laure Welter, MD, PhD, Principal investigator, GHPS, APHP, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469350
- Sponsor's protocol ID
- C15-12
- Other IDs
- RCB
- Acronym
- PARKGAME
- Status last verified
- Oct 2017
- First submitted
- 28 May 2015
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nuic D, Vinti M, Karachi C, Foulon P, Van Hamme A, Welter ML. The feasibility and positive effects of a customised videogame rehabilitation programme for freezing of gait and falls in Parkinson's disease patients: a pilot study. J Neuroeng Rehabil. 2018 Apr 10;15(1):31. doi: 10.1186/s12984-018-0375-x.
PubMed 29636105
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability Study of Serious Game Rehabilitation Program in Parkinson's Disease Patients With Resistant Gait and Balance Disorders
- ClinicalTrials.gov ID
- NCT02469350
- Acronym / sponsor ID
- PARKGAME / C15-12
- Conditions
- Parkinson's Disease
- Keywords
- Gait and balance disorders, serious game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Jun 2015 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 11 Jun 2015 (estimated)
- 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.
In this study the investigators aim to assess the feasibility and acceptability of a serious game to rehabilitate gait and balance disorders in 10 patients with Parkinson's disease previously operated for deep brain stimulation of the sub thalamic nucleus.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with serious game | Experimental | Other: Serious game18 rehabilitation sessions with serious game during a 6-8 weeks period |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease
- Gait and balance disorders
- Chronic bilateral deep brain stimulation of the subthalamic nucleus (> 1 year).
Key exclusion criteria (2 listed)
- Dementia
- Ongoing severe medical condition that prevented assessments
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 |
|---|---|---|
| Serious gameRehabilitation with serious game | Other | Rehabilitation with serious game |
Primary outcome
Feasibility questionnaire
Time frame: once a week
self-assessment questionnaire
3 secondary outcomes
Acceptability questionnaire
Time frame: once a week
biomechanical parameters of gait and balance
Time frame: at inclusion, 3 weeks, 6 weeks and 18 weeks
kinematics parameters of gait and balance
Time frame: at inclusion, 3 weeks, 6 weeks and 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 29636105Nuic D, Vinti M, Karachi C, Foulon P, Van Hamme A, Welter ML. The feasibility and positive effects of a customised videogame rehabilitation programme for freezing of gait and falls in Parkinson's disease patients: a pilot study. J Neuroeng Rehabil. 2018 Apr 10;15(1):31. doi: 10.1186/s12984-018-0375-x.
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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. This study is not recruiting at the moment.
Marie-Laure Welter, MD, PhD principal investigator
GHPS, APHP, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serious game in people with Parkinson's Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility questionnaire (time frame: once a week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02469350, which also lists 1 linked publication.
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 18 Nov 2025.