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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041997
Receipt No. 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 2020/10/31

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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
Email 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
Email h202c001@gunma-u.ac.jp

Sponsor
Institute Numata Neurosurgery & Heart Disease Hospital
Institute
Department

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
Email 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 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
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
2020 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047889

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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