UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled study to evaluate efficacy of specific rehabilitation to patients with idiopathic normal pressure hydrocephalus after shunt surgery
Title of the study (Brief title)	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	Masahiko Bundo
Organization	National center for geriatrics and gelontology
Division name	Department of neurosurgery
Address	7-430 Morioka-cho Obu Aichi
TEL	0562-46-2311
Email	ibundou@ncgg.go.jp

Public contact
Name of contact person	Masahiko Bundo
Organization	National center for geriatrics and gelontology
Division name	Department of neurosurgery
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 06 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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