Parkinson DiseaseREPEATNCT03958175
The Alouette Test in Parkinson Disease
An observational study of Parkinson Disease, run by Hospices Civils de Lyon.
Trial summary
Reading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of validated tests to screen for them. They are often attributed to hand tremors associated with the disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Alouette test (reading test)
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 1 Apr 2016
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had Parkinson's Disease
Who may be able to join
- Patients with Parkinson's Disease
- Montreal Cognitive Assessment (MoCA) test > 20
Who cannot join
- Patient's with supranuclear Palsy
- Other neurologic disease
- Any ophthalmologic disease
- Presence of a nystagmus
- Visual acuity < 0.6
About this study
Official title: Screening for Reading Difficulties in Parkinson's Disease: An Evaluation of the Alouette Test
Reading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of validated tests to screen for them. They are often attributed to hand tremors associated with the disease. In this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in PD by comparing the results to healthy patients.
- Conditions
- Parkinson Disease
- Being tested
- Alouette test (reading test)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alouette test (reading test)Other
The alouette test was assessed at a fixed distance of 40 centimeters on a fixed surface to avoid errors related to hand tremors.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson's Disease | Patients with Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia. Receives: Other: Alouette test (reading test) | |
| Patients without Parkinson's Disease = control group | Patients without Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia. Receives: Other: Alouette test (reading test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on the Alouette test
The Alouette test is based on the precision and speed in reading a short text (279 words). The score corresponds to the total number of words correctly read.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start1 Nov 2015
- Primary completion1 Apr 2016
- Study completion1 Apr 2016
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 Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thibaud Mathis, Dr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958175
- Sponsor's protocol ID
- REPEAT
- Acronym
- REPEAT
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 21 May 2019
- 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 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Reading Difficulties in Parkinson's Disease: An Evaluation of the Alouette Test
- ClinicalTrials.gov ID
- NCT03958175
- Acronym / sponsor ID
- REPEAT / REPEAT
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2016 (actual)
- First posted
- 21 May 2019 (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.
Reading disorders in Parkinson's Disease (PD) are poorly evaluated due to the lack of validated tests to screen for them. They are often attributed to hand tremors associated with the disease. In this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in PD by comparing the results to healthy patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson's Disease | – | Other: Alouette test (reading test)Patients with Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia. |
| Patients without Parkinson's Disease = control group | – | Other: Alouette test (reading test)Patients without Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had Parkinson's Disease
Key inclusion criteria (2 listed)
- Patients with Parkinson's Disease
- Montreal Cognitive Assessment (MoCA) test > 20
Key exclusion criteria (5 listed)
- Patient's with supranuclear Palsy
- Other neurologic disease
- Any ophthalmologic disease
- Presence of a nystagmus
- Visual acuity < 0.6
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 |
|---|---|---|
| Alouette test (reading test)The alouette test was assessed at a fixed distance of 40 centimeters on a fixed surface to avoid errors related to hand tremors. | Other | Patients with Parkinson's Disease, Patients without Parkinson's Disease = control group |
Primary outcome
Score on the Alouette test
Time frame: 1 day
The Alouette test is based on the precision and speed in reading a short text (279 words). The score corresponds to the total number of words correctly read.
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 21 May 2019.
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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.
Thibaud Mathis, Dr principal investigator
Hospices Civils de Lyon
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Hospices Civils de Lyon.
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 5 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 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Score on the Alouette test (time frame: 1 day). 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 21 May 2019.