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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023915
Receipt No. R000027395
Scientific Title A study of cognitive-behavioral interventions in rehabilitation to improve immobilization for patients with post-stroke depressive symptoms.
Date of disclosure of the study information 2016/09/03
Last modified on 2019/03/06

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Basic information
Public title A study of cognitive-behavioral interventions in rehabilitation to improve immobilization for patients with post-stroke depressive symptoms.
Acronym A study of cognitive-behavioral interventions for patients with post-stroke depressive symptoms.
Scientific Title A study of cognitive-behavioral interventions in rehabilitation to improve immobilization for patients with post-stroke depressive symptoms.
Scientific Title:Acronym A study of cognitive-behavioral interventions for patients with post-stroke depressive symptoms.
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study tests cognitive behavioral intervention to improve immbolization in post-stroke patients with depressive symptoms.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Main outcome is physical activity measured by Life Coda GS during intervention.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Cognitive behavioral intervention for stroke patients with depressive symptoms. Intervetnion programs are psychological education, breathing technique, attention bias modification and behavioral activation. Thsi intervention is carried out for 8 weeks.
Interventions/Control_2 Cognitive behavioral intervention for stroke patients with non-depressive symptoms. Intervetnion programs are psychological education, breathing technique, attention bias modification and behavioral activation. Thsi intervention is carried out for 8 weeks.
Interventions/Control_3 Occupational therapy in physical function for stroke patients with depressive symptoms. Intervetnion programs are patient education, attention bias modification(placebo), basic trainig and applied training. Thsi intervention is carried out for 8 weeks.
Interventions/Control_4 Occupational therapy in physical function for stroke patients with non-depressive symptoms. Intervetnion programs are patient education, attention bias modification(placebo), basic trainig and applied training. Thsi intervention is carried out for 8 weeks.
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 Inpatients with post-stroke depression and without post-stoke depression.
Stroke patients were required in Barthel Index score over 15 points.
Stroke patients were required in Mini-Mental State Examination score over 15 points.
Key exclusion criteria Stroke patients were difficalt to implemate test by aphasia.
The person and/or the family had depression in their history.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toyohiro Hamaguchi
Organization Saitama Prefectural University
Division name Department of Occupational Therapy
Zip code
Address 820 Sannomiya, Koshigaya City, Saitama
TEL 048-973-4125
Email hamaguchi-toyohiro@spu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toyohiro Hamaguchi
Organization Saitama Prefectural University
Division name Department of Occupational Therapy
Zip code
Address 820 Sannomiya, Koshigaya City, Saitama
TEL 048-973-4125
Homepage URL
Email hamaguchi-toyohiro@spu.ac.jp

Sponsor
Institute Saitama Prefectural University, Department of Occupational Therapy
Institute
Department

Funding Source
Organization no
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
Address
Tel
Email

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 戸田中央リハビリテーション病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 03 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
2016 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 14 Day
Last follow-up date
2019 Year 05 Month 01 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2019 Year 07 Month 20 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2019 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027395

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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