Parkinson DiseasePARKGAME-IINCT03560089
Serious Games Rehabilitation Programme to Treat Gait and Balance Disorders in PD Patients
A study testing Serious game in people with Parkinson Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Serious game
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jul 2018to 6 Dec 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease
- Gait and balance disorders resistant to dopaminergic medication
Who cannot join
- dementia
- contra-indication to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serious Games Rehabilitation Programme to Treat Gant and Balance Disorders in Patients With Parkinson's Disease
To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study
- Conditions
- Parkinson Disease
- Being tested
- Serious game, Placebo serious game
- Keywords
- Parkinson's disease, Gait, Rehabilitation, 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 gameDevice
Serious game with movements
Placebo serious gameDevice
Serious game without movement
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation with active serious game | Active comparator | 25 patients will perform motor rehabilitation programme using the serious game Receives: Device: Serious game |
| No active serious game | Placebo comparator | 25 patients will not perform motor rehabilitation programme using the serious game Receives: Device: Placebo serious game |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the time-up-go test
Measured: change between baseline and at 6 weeks
Secondary outcomes (9)
Duration of the time-up-go test
Measured: change between baseline and at 18 weeks
Step length
Measured: change between baseline and at 6 weeks
step velocity
Measured: change between baseline and at 6 weeks
Movement disorders Unified Parkinson's disease rating scale
Measured: change between baseline and at 6 weeks
freezing of gait questionnaire
Measured: change between baseline and at 6 weeks
Parkinson's disease quality of life scale
Measured: change between baseline and at 6 weeks
gait and balance scale
Measured: change between baseline and at 6 weeks
Montreal Cognitive Assessment
Measured: change between baseline and at 6 weeks
Magnetic resonance imaging
Measured: change between baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start18 Jul 2018
- Primary completion6 Dec 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marie Laure Welter, PH MD PHD, Principal investigator, ICM, 47 bd de l'Hôpital, 75013 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560089
- Sponsor's protocol ID
- C17-07
- Acronym
- PARKGAME-II
- Status last verified
- May 2025
- First submitted
- 15 May 2018
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PubMed 38588457Skrzatek A, Nuic D, Cherif S, Beranger B, Gallea C, Bardinet E, Welter ML. Brain modulation after exergaming training in advanced forms of Parkinson's disease: a randomized controlled study. J Neuroeng Rehabil. 2024 Aug 5;21(1):133. doi: 10.1186/s12984-024-01430-w.
PubMed 39103924Nuic D, van de Weijer S, Cherif S, Skrzatek A, Zeeboer E, Olivier C, Corvol JC, Foulon P, Pastor JZ, Mercier G, Lau B, Bloem BR, De Vries NM, Welter ML. Home-based exergaming to treat gait and balance disorders in patients with Parkinson's disease: A phase II randomized controlled trial. Eur J Neurol. 2024 Jan;31(1):e16055. doi: 10.1111/ene.16055. Epub 2023 Sep 10.
PubMed 37691341Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PubMed 36602886
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serious Games Rehabilitation Programme to Treat Gant and Balance Disorders in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03560089
- Acronym / sponsor ID
- PARKGAME-II / C17-07
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease, Gait, Rehabilitation, Serious game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 18 Jun 2018 (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.
To test the effects of a serious game rehabilitation programme in 50 patients with Parkinson's disease with gait and balance disorders in a randomised controlled study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation with active serious game | Active comparator | Device: Serious game25 patients will perform motor rehabilitation programme using the serious game |
| No active serious game | Placebo comparator | Device: Placebo serious game25 patients will not perform motor rehabilitation programme using the serious game |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parkinson's disease
- Gait and balance disorders resistant to dopaminergic medication
Key exclusion criteria (2 listed)
- dementia
- contra-indication to magnetic resonance imaging
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 gameSerious game with movements | Device | Rehabilitation with active serious game |
| Placebo serious gameSerious game without movement | Device | No active serious game |
Primary outcome
Duration of the time-up-go test
Time frame: change between baseline and at 6 weeks
9 secondary outcomes
Duration of the time-up-go test
Time frame: change between baseline and at 18 weeks
Step length
Time frame: change between baseline and at 6 weeks
step velocity
Time frame: change between baseline and at 6 weeks
Movement disorders Unified Parkinson's disease rating scale
Time frame: change between baseline and at 6 weeks
freezing of gait questionnaire
Time frame: change between baseline and at 6 weeks
Parkinson's disease quality of life scale
Time frame: change between baseline and at 6 weeks
gait and balance scale
Time frame: change between baseline and at 6 weeks
Montreal Cognitive Assessment
Time frame: change between baseline and at 6 weeks
Magnetic resonance imaging
Time frame: change between baseline and at 6 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 4 Dec 2025.
- Background: PubMed 38588457Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
- Results publication: PubMed 39103924Skrzatek A, Nuic D, Cherif S, Beranger B, Gallea C, Bardinet E, Welter ML. Brain modulation after exergaming training in advanced forms of Parkinson's disease: a randomized controlled study. J Neuroeng Rehabil. 2024 Aug 5;21(1):133. doi: 10.1186/s12984-024-01430-w.
- Results publication: PubMed 37691341Nuic D, van de Weijer S, Cherif S, Skrzatek A, Zeeboer E, Olivier C, Corvol JC, Foulon P, Pastor JZ, Mercier G, Lau B, Bloem BR, De Vries NM, Welter ML. Home-based exergaming to treat gait and balance disorders in patients with Parkinson's disease: A phase II randomized controlled trial. Eur J Neurol. 2024 Jan;31(1):e16055. doi: 10.1111/ene.16055. Epub 2023 Sep 10.
- Derived from this study: PubMed 36602886Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
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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, PH MD PHD principal investigator
ICM, 47 bd de l'Hôpital, 75013 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 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 2 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 4 Dec 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. Some participants in this study may receive a placebo. 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?
Duration of the time-up-go test (time frame: change between baseline and at 6 weeks). 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 NCT03560089, which also lists 4 linked publications.
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 4 Dec 2025.