UMIN-CTR Clinical Trial

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 and Pharmaceutical University Hospital
Division name	Department of Rehabilitation
Zip code	5698686
Address	2-7, Daigaku-machi, Takatsuki,Osaka
TEL	072-683-1221
Email	yasutaka.nikaido@ompu.ac.jp

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

Sponsor
Institute	Osaka Medical and Pharmaceutical University Hospital
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 and Pharmaceutical University
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	Published

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00415-022-11362-x
Number of participants that the trial has enrolled	70
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	Completed
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 03 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	2022 Year 11 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041173