UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036595 |
|---|---|
| Receipt number | R000041503 |
| Scientific Title | Palliative performance scale as a prognostic tool among Egyptian Parkinson's disease patients: a hospital based pilot study |
| Date of disclosure of the study information | 2019/04/25 |
| Last modified on | 2019/04/25 07:33:49 |
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Basic information
Public title
Palliative performance scale as a prognostic tool among Egyptian Parkinson's disease patients
Acronym
Palliative performance scale among Egyptian Parkinson's disease patients
Scientific Title
Palliative performance scale as a prognostic tool among Egyptian Parkinson's disease patients: a hospital based pilot study
Scientific Title:Acronym
Palliative performance scale among Egyptian Parkinson's disease patients
Region
| Africa |
Condition
Condition
Palliative performance scale
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesize that the PPS will be a potential predictor tool of disease progression among a sample of PD patients.
Basic objectives2
Others
Basic objectives -Others
predictor tool
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
change in clinical motor scales including H & Y scale and/or UPDRS (Part III and/or Total score) over time (6-month duration)
Key secondary outcomes
change in PPS score over time
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | < |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Egyptian patients diagnosed with IPD according to UK Parkinson's Disease Society Brain Bank Clinical Diagnostic criteria
Key exclusion criteria
Vascular PD (VP)
Parkinson plus syndrome (PPS) patients
cognitive impaired patients (MMSE=24 or abnormal for education level)
patients with negative levodopa challenge test
wheelchair bound or bed ridden patients, and severely disabled patients with Hoehn and Yahr scale (H & Y) stage 4 or 5
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Wael |
| Middle name | |
| Last name | Ibrahim |
Organization
Kasralainy hospital, Faculty of medicine, Cairo University; Egypt
Division name
Neurology
Zip code
11562
Address
Cairo
TEL
+201111919927
dr.wael_ezzat@residents.kasralainy.edu.eg
Public contact
Name of contact person
| 1st name | Wael |
| Middle name | |
| Last name | Wael Ibrahim |
Organization
Kasralainy hospital, Faculty of Medicine, Cairo University
Division name
Neurology
Zip code
12411
Address
37 elhassan street, dokki
TEL
+201111919927
Homepage URL
dr.wael_ezzat@yahoo.com
Sponsor or person
Institute
Kasralainy hospital, Faculty of medicine, Cairo University; Egypt
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
scientific & ethical committee of neurology department, faculty of medicine, Cairo university
Address
Kasr Al Ainy St. Cairo, Egypt
Tel
(202)23682030
Admin@kasralainy.edu.eg
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
pilot prospective Cohort involving a sample of Egyptian PD patients at Kasralainy hospital, Cairo university
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
