UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045254 |
|---|---|
| Receipt number | R000051652 |
| Scientific Title | Effect of the self-monitoring approach from acute phase on physical activity in patients with mild ischemic stroke -A randomized controlled trial- |
| Date of disclosure of the study information | 2021/08/25 |
| Last modified on | 2023/09/10 15:15:20 |
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Basic information
Public title
Effect of the self-monitoring approach from acute phase on physical activity in patients with mild ischemic stroke -A randomized controlled trial-
Acronym
Effect of the self-monitoring approach from acute phase on physical activity in patients with mild ischemic stroke
Scientific Title
Effect of the self-monitoring approach from acute phase on physical activity in patients with mild ischemic stroke -A randomized controlled trial-
Scientific Title:Acronym
Effect of the self-monitoring approach from acute phase on physical activity in patients with mild ischemic stroke
Region
| Japan |
Condition
Condition
Ischemic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the effect of the self-monitoring approach from acute phase to post discharge on physical activity in patients with mild ischemic stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Steps
Key secondary outcomes
Physical activity
Self efficacy physical activity
30-second chair stand test
Grip strength
10m-walk test
Time up and go test
Blood laboratory date
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group
Self-monitoring approach and usual rehabilitation during hospitalization
Until 6 months after discharge self-monitoring approach
1,3,6month after discharge outpatient support
Continued support on the phone or mail more than once a month
Interventions/Control_2
Control group
Usual rehabilitation during hospitalization
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
Ischemic stroke patients who hospitalized at our hospital neurosurgery and rehabilitated
Ischemic stroke patients who could walk without assistance within 1 week after admission
Patients who obtained consent of this research
Patients who can attend our hospital
Key exclusion criteria
Patients with dementia , cognitive dysfunction
Patients who can't continue to wear activity tracker
Patients with other diseases limit to activity
Patients who had recurrence , other diseases limit to activity during intervention
Patients who is difficult to write monitoring list due to severe hemiplegic upper limb
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yayoi |
| Middle name | |
| Last name | Itoh |
Organization
Southern TOHOKU General Hospital
Division name
Rehabilitation department
Zip code
963-8563
Address
7-115,Yatsuyamada,Koriyama,Fukushima
TEL
0249345322
chrischan1225@hotmail.com
Public contact
Name of contact person
| 1st name | Yayoi |
| Middle name | |
| Last name | Itoh |
Organization
Southern TOHOKU General Hospital
Division name
Rehabilitation department
Zip code
963-8563
Address
7-115,Yatsuyamada,Koriyama,Fukushima
TEL
0249345322
Homepage URL
chrischan1225@hotmail.com
Sponsor or person
Institute
Southern TOHOKU General Hospital
Rehabilitation department
Institute
Department
Personal name
Funding Source
Organization
None
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
Southern TOHOKU General Hospital
Address
7-115,Yatsuyamada,Koriyama,Fukushima
Tel
0249345322
chrischan1225@hotmail.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
一般財団法人脳神経疾患研究所付属総合南東北病院(福島県)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 25 | 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
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 25 | Day |
Last modified on
| 2023 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051652
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
