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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023641
Receipt No. 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 2019/03/28

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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
Email 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
Email ak-yamasaki@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

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
Email 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 55
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
2019 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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