UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023641 |
|---|---|
| Receipt number | R000027224 |
| Scientific Title | Do neuropsycological tests including procedural learning ability or brain MRI imaging predict efficacy of rehabilitation in Parkinson Disease |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2020/02/21 12:08:41 |
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Basic information
Public title
Do neuropsycological tests including procedural learning ability or brain MRI imaging predict efficacy of rehabilitation in Parkinson Disease
Acronym
Do neuropsycological tests including procedural learning ability or brain MRI imaging predict efficacy of rehabilitation in Parkinson Disease
Scientific Title
Do neuropsycological tests including procedural learning ability or brain MRI imaging predict efficacy of rehabilitation in Parkinson Disease
Scientific Title:Acronym
Do neuropsycological tests including procedural learning ability or brain MRI imaging predict efficacy of rehabilitation in Parkinson Disease
Region
| Japan |
Condition
Condition
Parkinson disease
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relevance between the efficacy of the rehabilitation and neuropsycological tests including procedural learning ability or brain MRI image in Parkinson Disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The assessments will be done on the time of admission, discharge, 3 months, 6 months, 12months after discharge, respectively.
The primary outcome is the UPDRS part 2.
Key secondary outcomes
The UPDRS part 3, the mini-BESTest, the 10m walk time.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
8 weeks in-patient comprehensive rehabilitation
button press task
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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hoehn-Yahr 1-3
Key exclusion criteria
Dementia, post-stroke, other movement disorders
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo college of medicine
Division name
Department of rehabilitation medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo, Japan
TEL
0798-45-6881
office@craseed.org
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Yamasaki |
Organization
Hyogo Prefectural Rehabilitation Hospital at NIshi-Harima
Division name
Department of rehabilitation medicine
Zip code
679-5165
Address
7-1 Koto 1-chome, Shingu-cho, Tatsuno city, Hyogo, Japan
TEL
0791-58-1050
Homepage URL
ak-yamasaki@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hyogo Prefectural Rehabilitation Hospital at NIshi-Harima
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of college of medicine
Address
1-1, Mukogawa-cho, Nishinomiya city, Hyogo, Japan
Tel
0798-45-6066
rinri@hyo-med.ac.jp
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
兵庫県立リハビリテーション西播磨病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 16 | 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
35
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 16 | Day |
Last modified on
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027224
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
