UMIN-CTR Clinical Trial

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
Email	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
Email	k_miura@saitama-med.ac.jp

Sponsor
Institute	Amakusa rehabilitation hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035751