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出境医 / 临床实验 / The Alouette Test in Parkinson Disease (REPEAT)
The Alouette Test in Parkinson Disease (REPEAT)
Study Description
Brief 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. In this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in PD by comparing the results to healthy patients.
| Condition or disease | Intervention/treatment |
|---|---|
| Parkinson Disease | Other: Alouette test (reading test) |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 38 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Screening for Reading Difficulties in Parkinson's Disease: An Evaluation of the Alouette Test |
| Actual Study Start Date : | November 1, 2015 |
| Actual Primary Completion Date : | April 1, 2016 |
| Actual Study Completion Date : | April 1, 2016 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Patients with Parkinson's Disease
Patients with Parkinson's Disease (PD) were evaluated for reading disorders using a screening method validated for dyslexia.
|
Other: 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.
|
|
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.
|
Other: 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.
|
Outcome Measures
Primary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who had Parkinson's Disease
Criteria
Inclusion Criteria:
- Patients with Parkinson's Disease
- Montreal Cognitive Assessment (MoCA) test > 20
Exclusion Criteria:
- Patient's with supranuclear Palsy
- Other neurologic disease
- Any ophthalmologic disease
- Presence of a nystagmus
- Visual acuity < 0.6
Contacts and Locations
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Thibaud Mathis, Dr | Hospices Civils de Lyon |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | May 21, 2019 | ||||
| Actual Study Start Date | November 1, 2015 | ||||
| Actual Primary Completion Date | April 1, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | The Alouette Test in Parkinson Disease | ||||
| Official Title | Screening for Reading Difficulties in Parkinson's Disease: An Evaluation of the Alouette Test | ||||
| Brief 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. In this study, the investigating team evaluated the "alouette test" validated for dyslexia screening, in PD by comparing the results to healthy patients. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients who had Parkinson's Disease | ||||
| Condition | Parkinson Disease | ||||
| Intervention | Other: 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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
38 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | April 1, 2016 | ||||
| Actual Primary Completion Date | April 1, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03958175 | ||||
| Other Study ID Numbers | REPEAT | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Hospices Civils de Lyon | ||||
| Study Sponsor | Hospices Civils de Lyon | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Hospices Civils de Lyon | ||||
| Verification Date | May 2019 | ||||
