Parkinson DiseaseRGPNCT02855710
A Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
A study testing Rhythm workers training Perceptive timing, Rhythm workers training sensorimotor timing and No Rhythm workers training in people with Parkinson Disease, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Rhythm workers training Perceptive timing, Rhythm workers training sensorimotor timing and No Rhythm workers training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2016to Jan 2022
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age < 18
- good understanding of the nature, the goal and the methodology of the study
- signing of the informed consent
- being insured with a social security
- Diagnostic of idiopathic Parkinson's disease following the Queen Square Brain Bank (Hughes, 1992)
- Hoehn et Yahr between 2 and 3
- mild to moderate walk and speech deficits (Item MDS-UPDRS)
- stable therapy one month before inclusion for all the duration of the study
Who cannot join
- Atypic Parkinson Syndrom (oculomotor troubles, early falls, hallucinations, MoCA<20, early dysautonomy)
- dystonia ou dyskinesia preventing from using a tablet (item MDS-UPDRS4.2 >2)
- Unable to move without help (walking stick, walker, wheelchair) (item MDS-UPDRS 2.12 >2)
- adult protected by law
- deprivation of liberty
- High propability of non compliance to the protocol
Show all 17Show fewer
- pregnant women, nursing women
- moderate to severe auditory trouble
- Severe walk fluctuations item MDS-UPDRS 4.4 >2)
- Pacemaker or neurosensorial device or heart defebrillator
- Cochlear implants
- ferromagnetic external bodies claose to the brain
- Metallic prothesis
- agitated, non cooperative patient
- claustrophobic patient
- neuro-surgical shunt valves
- dental appliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rhythm Game Park: a Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost tool for rehabilitation.
Read the detailed description
Auditory rythmic cueing is a method consisting in presenting a regular auditory stimulus (metronom or music) when someone is walking. It is known to improve gait in pathologies such as Parkinson's disease. It has also an effect on general timing abilities (e.g. tapping the beat of the music). This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overal, we propose to test a low-cost tool for rehabilitation.
- Conditions
- Parkinson Disease
- Being tested
- Rhythm workers training Perceptive timing, Rhythm workers training sensorimotor timing, No Rhythm workers training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythm workers training Perceptive timingOther
Perceptive timing training
Rhythm workers training sensorimotor timingOther
Sensorimotor timing training
No Rhythm workers trainingOther
No training
| Study group | Role | What they receive |
|---|---|---|
| No training | Other | Parkinsonian Patients with no Rhythm Workers training perceptive timing and senrorimotor timing Receives: Other: No Rhythm workers training |
| Perceptive timing training | Other | Parkinsonian Patients with Rhythm Workers training perceptive timing Receives: Other: Rhythm workers training Perceptive timing |
| Sensorimotor timing training | Other | Parkinsonian Patients with Rhythm Workers training sensorimotor timing Receives: Other: Rhythm workers training sensorimotor timing |
| Healthy volunteers | Other | Healthy people with Rhythm Workers training perceptive timing Receives: Other: Rhythm workers training Perceptive timing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rythmic capacities
Evaluate the effect of the training of the rythmic capacities (Sensorimotor timing abilities) on the walk and the speak
Measured: 3 months
Secondary outcomes (2)
cognitive functions
Evaluate the cognitive functions by Neurospsychologic tests
Measured: 3 months
Mesure of the neural reorganisation
Evaluate the structure et connectivity by MRI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study start4 Mar 2016
- Primary completionJan 2019
- Study completionJan 2022 (estimated)
Why it stopped: end of inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory Parole et Langage UMR 7309, Laboratory EUROMOV EA 2991, Université Montpellier
- Responsible party
- Sponsor
- Investigators
- Christian Gény, MD, Study chair, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855710
- Sponsor's protocol ID
- 9499
- Acronym
- RGP
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2016
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rhythm Game Park: a Training of the Rhythmic Skills With a Serious Game to Improve Gait and Cognitive Abilities in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02855710
- Acronym / sponsor ID
- RGP / 9499
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: end of inclusion period
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Laboratory Parole et Langage UMR 7309, Laboratory EUROMOV EA 2991, Université Montpellier
- Study start
- 4 Mar 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2022 (estimated)
- First posted
- 4 Aug 2016 (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.
This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overall, we propose to test a low-cost tool for rehabilitation.
Detailed description
Auditory rythmic cueing is a method consisting in presenting a regular auditory stimulus (metronom or music) when someone is walking. It is known to improve gait in pathologies such as Parkinson's disease. It has also an effect on general timing abilities (e.g. tapping the beat of the music). This project aims at assessing the opposite relation, namely the effect of a training of the general timing abilities on gait in Parkinson's disease. Timing rehabilitation will be done by the means of a serious game. Serious games are more and more used to improve the compliance and the efficacy of reeducaiton programs. Overal, we propose to test a low-cost tool for rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No training | Other | Other: No Rhythm workers trainingParkinsonian Patients with no Rhythm Workers training perceptive timing and senrorimotor timing |
| Perceptive timing training | Other | Other: Rhythm workers training Perceptive timingParkinsonian Patients with Rhythm Workers training perceptive timing |
| Sensorimotor timing training | Other | Other: Rhythm workers training sensorimotor timingParkinsonian Patients with Rhythm Workers training sensorimotor timing |
| Healthy volunteers | Other | Other: Rhythm workers training Perceptive timingHealthy people with Rhythm Workers training perceptive timing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- age < 18
- good understanding of the nature, the goal and the methodology of the study
- signing of the informed consent
- being insured with a social security
- Diagnostic of idiopathic Parkinson's disease following the Queen Square Brain Bank (Hughes, 1992)
Key exclusion criteria (17 listed)
- Atypic Parkinson Syndrom (oculomotor troubles, early falls, hallucinations, MoCA<20, early dysautonomy)
- dystonia ou dyskinesia preventing from using a tablet (item MDS-UPDRS4.2 >2)
- Unable to move without help (walking stick, walker, wheelchair) (item MDS-UPDRS 2.12 >2)
- adult protected by law
- deprivation of liberty
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 |
|---|---|---|
| Rhythm workers training Perceptive timingPerceptive timing training | Other | Healthy volunteers, Perceptive timing training |
| Rhythm workers training sensorimotor timingSensorimotor timing training | Other | Sensorimotor timing training |
| No Rhythm workers trainingNo training | Other | No training |
Primary outcome
Rythmic capacities
Time frame: 3 months
Evaluate the effect of the training of the rythmic capacities (Sensorimotor timing abilities) on the walk and the speak
2 secondary outcomes
cognitive functions
Time frame: 3 months
Mesure of the neural reorganisation
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Christian Gény, MD study chair
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhythm workers training Perceptive timing, Rhythm workers training sensorimotor timing and No Rhythm workers training in people with Parkinson Disease, run by University Hospital, Montpellier 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 8 inclusion and 17 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: paused, as of the sponsor's last update on 29 Dec 2021. 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?
Results are not available in the source record.
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?
Rythmic capacities (time frame: 3 months). 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 29 Dec 2021.