UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041997 |
|---|---|
| Receipt number | R000047889 |
| Scientific Title | Validity of the 6-minute walk test in subacute mild stroke patients. |
| Date of disclosure of the study information | 2020/10/05 |
| Last modified on | 2023/03/05 22:50:44 |
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Basic information
Public title
Validity of the 6-minute walk test in subacute mild stroke patients
Acronym
Validity of the 6-minute walk test in subacute mild stroke patients
Scientific Title
Validity of the 6-minute walk test in subacute mild stroke patients.
Scientific Title:Acronym
Validity of the 6-minute walk test in subacute mild stroke patients.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the validity of the 6-minute walk test for subacute mild stroke patients.
Basic objectives2
Others
Basic objectives -Others
To clarify the prognostic effect of the 6-minute walk test for subacute mild stroke patients.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
6-minute walk test
Key secondary outcomes
Brunnstrom Recovery stage
Functional Ambulation Category
Comfortable Walking Speed
Mini-Balance Evaluation Systems test
modified Dynamic Gait Index
Functional Independence Measure
Falls Efficacy Scale-International
modified Functional Walking Category
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Over 20 years and older
2) Medically stable condition
3) Hospitalized for a stroke
4) Functional Ambulation Category is 3 or more
Key exclusion criteria
1) Previous history of severe neuromuscular disease, respiratory and circulatory disease, dementia
2) Unable to understand the instructions
3) pre-morbid modified rankin scale of 2 or more
4) Cases of death
5) Disagreement to participate in the study
6) Unstable angina or myocardial infarction in the previous month
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Igarashi |
Organization
Numata Neurosurgery & Heart Disease Hospital
Division name
Department of Rehabilitation
Zip code
378-0014
Address
8 Sakaemachi, Numata-shi, Gumma 378-0014, Japan
TEL
0278-22-5052
h202c001@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Igarashi |
Organization
Numata Neurosurgery & Heart Disease Hospital
Division name
Department of Rehabilitation
Zip code
378-0014
Address
8 Sakaemachi, Numata-shi, Gumma 378-0014, Japan
TEL
0278-22-5052
Homepage URL
h202c001@gunma-u.ac.jp
Sponsor or person
Institute
Numata Neurosurgery & Heart Disease Hospital
Institute
Department
Personal name
Funding Source
Organization
Gunma University Graduate School of Health Sciences
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
Numata Neurosurgery & Heart Disease Hospital
Address
8 Sakaemachi, Numata-shi, Gumma 378-0014, Japan
Tel
0278-22-5052
nn-soumu@kijokai.or.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
| 2020 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
78
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
| 2020 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
A 6-minute walk test and other items will be assessed within 1 week of discharge from the hospital in patients with subacute mild stroke. A follow-up telephone survey will be conducted 6 months after discharge from the hospital. The study will begin in October 2020 and will run until December 2022.
Management information
Registered date
| 2020 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047889
