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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033072
Receipt No. R000037712
Scientific Title Randomized controlled study to evaluate efficacy of specific rehabilitation to patients with idiopathic normal pressure hydrocephalus after shunt surgery
Date of disclosure of the study information 2018/08/01
Last modified on 2018/06/20

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Basic information
Public title Randomized controlled study to evaluate efficacy of specific rehabilitation to patients with idiopathic normal pressure hydrocephalus after shunt surgery
Acronym Study of Post-Operative Rehabilitation for INPH patients (SPORI)
Scientific Title Randomized controlled study to evaluate efficacy of specific rehabilitation to patients with idiopathic normal pressure hydrocephalus after shunt surgery
Scientific Title:Acronym Study of Post-Operative Rehabilitation for INPH patients (SPORI)
Region
Japan

Condition
Condition Idiopathic normal pressure hydrocephalus
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of specific rehabilitation to patients with idiopathic normal pressure hydrocephalus after shunt surgery
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes improvement in modified Rankin scale 3 months after shunt surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Shunt surgery plus rehabilitation (2 weeks)
Interventions/Control_2 Only shunt surgery
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
70 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria iNPH patients between 2 and 4 points in the modified Rankin scale
Key exclusion criteria Patients with severe cognitive or musculoskeletal impairment which id too severe to
execution the rehabilitation
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Bundo
Organization National center for geriatrics and gelontology
Division name Department of neurosurgery
Zip code
Address 7-430 Morioka-cho Obu Aichi
TEL 0562-46-2311
Email ibundou@ncgg.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiko Bundo
Organization National center for geriatrics and gelontology
Division name Department of neurosurgery
Zip code
Address 7-430 Morioka-cho Obu Aichi
TEL 0562-46-2311
Homepage URL
Email ibundou@ncgg.go.jp

Sponsor
Institute National center for geriatrics and gelontology
Institute
Department

Funding Source
Organization National center for geriatrics and gelontology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 06 Month 20 Day
Last modified on
2018 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037712

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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