UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033072 |
|---|---|
| Receipt number | 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 21:10:40 |
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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
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
ibundou@ncgg.go.jp
Sponsor or person
Institute
National center for geriatrics and gelontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037712
