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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029387
Receipt No. R000033580
Scientific Title effect of social rewards on stroke rehabilitation
Date of disclosure of the study information 2017/11/01
Last modified on 2019/03/13

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Basic information
Public title effect of social rewards on stroke rehabilitation
Acronym effect of social rewards on stroke rehabilitation
Scientific Title effect of social rewards on stroke rehabilitation
Scientific Title:Acronym effect of social rewards on stroke rehabilitation
Region
Japan

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

Objectives
Narrative objectives1 The purpose of the study is to examine the effect of social rewards on intrinsic motivation of stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes total time of voluntary participation on rehabilitation
Key secondary outcomes 1. total running distance during voluntary participation on rehabilitation
2. Visual Analog Scale of motivation
3. apathy scale
4. depression scale

Base
Study type Interventional

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

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Five min of praise during rehabilitation / washout: more than 24 hours / 5 min of communication / washout: more than 24 hours / 5 min of watchful waiting
Interventions/Control_2 Five min of praise during rehabilitation / washout: more than 24 hours / 5 min of watchful waiting / washout: more than 24 hours / 5 min of communication
Interventions/Control_3 Five min of communication during rehabilitation / washout: more than 24 hours /5 min of praise / washout: more than 24 hours / 5 min of watchful waiting
Interventions/Control_4 Five min of communication during rehabilitation / washout: more than 24 hours / 5 min of watchful waiting / washout: more than 24 hours/ 5 min of praise
Interventions/Control_5 Five min of watchful waiting during rehabilitation / washout: more than 24 hours / 5 min of praise / washout: more than 24 hours / 5 min of communication
Interventions/Control_6 Five min of watchful waiting during rehabilitation / washout: more than 24 hours / 5 min of communication / washout: more than 24 hours/ 5 min of praise
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. stroke patients
2. more than one month after stroke onset
3. a Mini Mental Status Examination score of >20 points. No higher brain dysfunction including aphasia
4. patients who can use a bicycle ergometer more than 5 min.
5. patients who can use a bicycle ergometer safely without risk of falling.
6. patients who use a bicycle ergometer in their daily rehabilitation program
7. patients who enter hospital more than one week
8. patients who agree to participate in this study

Key exclusion criteria 1. patients who meet withdraw criteria proposed by the Japanese Association of Rehabilitation Medicine
2. patients who have arthrogryposis, orthopedic disease or pain that prevent them to perform motor tasks used in the study.
3. patients who have neurological disease other than stroke
4. patients who have psychiatric disease
5. patients who are considered to be inappropriate to participate in the study
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Kaori
Middle name
Last name Takahashi
Organization Tokyo Bay Rehabilitation Hospital
Division name Division of Rehabilitation
Zip code 275-0026
Address 4-1-1 Yatsu, Narashino-City, Japan
TEL 047-453-9000
Email pt-tbr@wanrhha.net

Public contact
Name of contact person
1st name Kaori
Middle name
Last name Takahashi
Organization Tokyo Bay Rehabilitation Hospital
Division name Division of Rehabilitation
Zip code 275-0026
Address 4-1-1 Yatsu, Narashino-City, Japan
TEL 047-453-9000
Homepage URL
Email pt-tbr@wanrhha.net

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor Hamamatsu University School of Medicine
International University of Health and Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Bay Rehabilitation Hospital
Address 4-1-1 Yatsu, Narashino-City, Japan
Tel 047-453-9000
Email pt-tbr@wanrhha.net

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 東京湾岸リハビリテーション病院(千葉県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 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 Enrolling by invitation
Date of protocol fixation
2017 Year 08 Month 11 Day
Date of IRB
2017 Year 08 Month 11 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2020 Year 04 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 02 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033580

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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