UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031380 |
|---|---|
| Receipt number | R000035751 |
| Scientific Title | Planning intervention for activity and participation of stroke survivors |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2022/08/25 09:17:38 |
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Basic information
Public title
Planning intervention for activity and participation of stroke survivors
Acronym
Planning intervention for activity and participation of stroke survivors
Scientific Title
Planning intervention for activity and participation of stroke survivors
Scientific Title:Acronym
Planning intervention for activity and participation of stroke survivors
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study of stroke survivors was conducted to clarify changes in activity and participation that occur during and after planning intervention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
activity and participation state
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
planning for activity or participation after discharge (1 time/month)
Interventions/Control_2
standard rehabilitation
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
first ever stroke
Key exclusion criteria
communicative difficulties
serious past illness
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ozawa |
Organization
Amakusa rehabilitation hospital
Division name
Rehabilitation division
Zip code
3430002
Address
341-1 hirakata koshigaya-citiy, saitama-pref, JAPAN
TEL
048-974-1171
k_konuma@icloud.com
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Miura |
Organization
Saitama medical university
Division name
Faculty on health and medical care
Zip code
3500496
Address
981 kawakado, moroyama-machi, iruma-gun, saitama-pref, JAPAN
TEL
049-295-8269
Homepage URL
k_miura@saitama-med.ac.jp
Sponsor or person
Institute
Amakusa rehabilitation hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuculty of Health &Medical, Research Ethics Committee
Address
1397-1 Yamane Hidaka-city Saitama-pref, Japan
Tel
0429844801
k_miura@saitama-med.ac.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
| 2018 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 02 | Month | 20 | Day |
Last modified on
| 2022 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035751
