UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036791 |
|---|---|
| Receipt number | 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 | 2022/11/21 06:55:36 |
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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 and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
5698686
Address
2-7, Daigaku-machi, Takatsuki,Osaka
TEL
072-683-1221
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
yasutaka.nikaido@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041173
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
