![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047668 |
Receipt No. | R000054346 |
Scientific Title | Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients |
Date of disclosure of the study information | 2022/05/15 |
Last modified on | 2022/05/06 |
Basic information | ||
Public title | Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients | |
Acronym | Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients | |
Scientific Title | Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients | |
Scientific Title:Acronym | Relationships between brain lesion location, sensory deficits, and sense of ownership/agency changes over time in subacute stroke patients | |
Region |
|
Condition | |||
Condition | Stroke | ||
Classification by specialty |
|
||
Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate the brain mechanisms that cause sensory deficit and sense of ownership/agency changes after stroke. |
Basic objectives2 | Safety |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Phase I |
Assessment | |
Primary outcomes | Bedside Quantitative Sensory Testing of after admission to the rehabilitation ward and 1 month, 2 months ,3 months |
Key secondary outcomes | Fugl-Meyer Assessment upper/lower limb sensory score, sense of ownership/agency questionnaire of after admission to the rehabilitation ward and 1 month, 2 months ,3 months |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
Interventions/Control_2 | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Stroke patients with and without sensory deficit | |||
Key exclusion criteria | Persons with complications of sensory disorders originating from peripheral nerves, such as diabetes mellitus, or from spinal nerve roots, such as spinal canal stenosis
Mini Mental State Examination-J (MMSE-J) <= 23 Patients with aphasia who cannot understand the research or the explanation of the assignment. |
|||
Target sample size | 60 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | JCHO Hoshigaoka Medical Center | ||||||
Division name | Department of Rehabilitation | ||||||
Zip code | 573-8511 | ||||||
Address | 4-8-1 Hoshigaoka, Hirakata City, Osaka | ||||||
TEL | 072-840-2641 | ||||||
kinoshita.shiori.0906@gmail.com |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | JCHO Hoshigaoka Medical Center | ||||||
Division name | Department of Rehabilitation | ||||||
Zip code | 573-8511 | ||||||
Address | 4-8-1 Hoshigaoka, Hirakata City, Osaka | ||||||
TEL | 072-840-2641 | ||||||
Homepage URL | |||||||
kinoshita.shiori.0906@gmail.com |
Sponsor | |
Institute | Kio university |
Institute | |
Department |
Funding Source | |
Organization | Kio university |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | JCHO Hoshigaoka Medical Center |
Address | 4-8-1 Hoshigaoka, Hirakata City, Osaka |
Tel | 072-840-2641 |
kinoshita.shiori.0906@gmail.com |
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 |
|
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 | Preinitiation | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Study design: Cross-sectional study
Recruitment methods: Patients admitted to our hospital's convalescence rehabilitation ward who meet the selection and exclusion criteria are included. |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054346 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |