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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036791
Receipt No. R000041173
Scientific Title Effects of the rehabilitation intervention based on gait and balance disturbance in idiopathic normal pressure hydrocephalus
Date of disclosure of the study information 2019/05/20
Last modified on 2019/05/24

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Basic information
Public title Effects of the rehabilitation intervention based on gait and balance disturbance in idiopathic normal pressure hydrocephalus
Acronym Rehabilitation in idiopathic normal pressure hydrocephalus
Scientific Title Effects of the rehabilitation intervention based on gait and balance disturbance in idiopathic normal pressure hydrocephalus
Scientific Title:Acronym Rehabilitation in idiopathic normal pressure hydrocephalus
Region
Japan

Condition
Condition idiopathic normal pressure hydrocephalus
Classification by specialty
Neurology Surgery in general Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of the rehabilitation intervention based on gait and balance disturbance in idiopathic normal pressure hydrocephalus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Gait Assessment (7 weeks, 6 months after cerebrospinal fluid shunt surgery)
Key secondary outcomes Berg Balance Scale, Timed UP and Go test, 10-m walk test (7 weeks, 6 months after cerebrospinal fluid shunt surgery)
Modified Rankin Scale, Life Space Assessment, History of falls (6 months after cerebrospinal fluid shunt surgery)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Equilibrium function-oriented gait training (after shunt surgery, 60 min/session, 6 weeks, self-exercise pamphlet)
Interventions/Control_2 Standard exercise (after shunt surgery,60 min/session, 6 weeks, self-exercise pamphlet)
Interventions/Control_3 After shunt surgery,natural corse (no rehabilitation intervention)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The participants have probable diagnoses with positive results of tap test according to the idiopathic normal pressure hydrocephalus (iNPH) diagnostic criteria. They will undergo lumboperitoneal or ventriculoperitoneal shunt surgeries.
Key exclusion criteria Addtional neurological disease other than idiopathic normal pressure hydrocephalus (i.e., Parkinson's disease, Alzheimer's disease, progressive supranuclear palsy, vascular parkinsonism, etc.)
Additional orthopedic disorders or pain interfering with gait
Inability to walk unassisted
No gotton understanding and cooperative
No gotton contsent for participation
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Yasutaka
Middle name
Last name Nikaido
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Zip code 5698686
Address 2-7, Daigaku-machi, Takatsuki,Osaka
TEL 072-683-1221
Email reh055@osaka-med.ac.jp

Public contact
Name of contact person
1st name Yasutaka
Middle name
Last name Nikaido
Organization Osaka Medical College Hospital
Division name Department of Rehabilitation
Zip code 569-8686
Address 2-7,Daigaku-machi,Takatsuki,Osaka
TEL 072-683-1221
Homepage URL
Email reh055@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization None
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 The ethics committee at Osaka Medical College
Address 2-7, Daigaku-machi, Takatsuki,Osaka
Tel 072-683-1221
Email rinri@art.osaka-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

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 20 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
2019 Year 05 Month 07 Day
Date of IRB
2019 Year 05 Month 07 Day
Anticipated trial start date
2019 Year 05 Month 20 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 18 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041173

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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