UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050177 |
|---|---|
| Receipt number | R000057151 |
| Scientific Title | Importance of the gait component in subacute stroke patients: A mixed method research design |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/08/01 12:38:12 |
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Basic information
Public title
Importance of the gait component in subacute stroke patients: A mixed method research design
Acronym
Importance of the gait component in subacute stroke patients
Scientific Title
Importance of the gait component in subacute stroke patients: A mixed method research design
Scientific Title:Acronym
Importance of the gait component in subacute stroke patients
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate gait elements perceived as important by subacute stroke patients
Basic objectives2
Others
Basic objectives -Others
Factual Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Semi structured interview
Content analysis
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subacute stroke patients with onset of 3 months who were admitted to a convalescent rehabilitation ward
Key exclusion criteria
Difficulty in conducting or understanding the interview
The score of MMSE is less 23
Inability to walk before stroke onset
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Mitsue |
Organization
Kio University
Division name
Department of Neurorehabilitation
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo, Kitakatsuragi-gun, Nara
TEL
+81-745-54-1601
mitsue0404@outlook.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Mitsue |
Organization
Itami Kousei Neurosurgical Hospital
Division name
Department of Rehabilitation
Zip code
6640028
Address
1-300-1, Nishino, Itami-shi, Hyogo
TEL
072-781-6600
Homepage URL
mitsue0404@outlook.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
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
Itami Kousei Neurosurgical Hospital
Address
1-300-1, Nishino, Itami-shi, Hyogo
Tel
072-781-6600
mitsue0404@outlook.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
| 2023 | Year | 02 | Month | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Cross-sectional study
Method of recruitment of subjects: Subacute stroke patients with onset of 3 months who were admitted to a convalescent rehabilitation ward
Outcomes: Semi-structured interview, walking ability assessment
Management information
Registered date
| 2023 | Year | 01 | Month | 30 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057151
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
