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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027646
Receipt No. R000031667
Scientific Title Consideration of the Effectiveness of HANDS Therapy for the Treatment of Upper Extremity Hemiplegia Dysfunction
Date of disclosure of the study information 2017/06/10
Last modified on 2019/06/11

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Basic information
Public title Consideration of the Effectiveness of HANDS Therapy for the Treatment of Upper Extremity Hemiplegia Dysfunction
Acronym Consideration of the Effectiveness of HANDS Therapy
Scientific Title Consideration of the Effectiveness of HANDS Therapy for the Treatment of Upper Extremity Hemiplegia Dysfunction
Scientific Title:Acronym Consideration of the Effectiveness of HANDS Therapy
Region
Japan

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

Objectives
Narrative objectives1 Efficacy of HANDS Therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ROM-t,Upper limb function evaluation,Muscle tone evalustion
Key secondary outcomes FIM,FAI

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 4
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 3weeks before HANDS therapy intervention
Interventions/Control_2 Before HANDS therapy intervention
Interventions/Control_3 After HANDS therapy intervention for 3weeks for 8 hours in a day
Interventions/Control_4 3weeks later after HANDS therapy intervention
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 The patient who receives rehabilitation of our hospital where five months or more passed after the cerebrovascular disorder onset
Key exclusion criteria The patient who doesn't have a severe contracture to severe dementia, highly advanced brain functional disorder, unilateral spacial neglect, a finger
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyo Shigeta
Organization The Kitasato University Kitasato Institute Hospital







































Division name Department of Rehabilitation
Zip code
Address 5-9-1,Shirokane,Minato-ku,Tokyo
TEL 03-5791-6157
Email junishi@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kyo Shigeta
Organization The Kitasato University Kitasato Institute Hospital
Division name Department of Rehabilitation
Zip code
Address 5-9-1,Shirokane,Minato-ku,Tokyo
TEL 03-5791-6157
Homepage URL
Email junishi@insti.kitasato-u.ac.jp

Sponsor
Institute The Kitasato University Kitasato Institute Hospital
Institute
Department

Funding Source
Organization The Kitasato University Kitasato Institute Hospital
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 10 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 Completed
Date of protocol fixation
2016 Year 09 Month 06 Day
Date of IRB
2016 Year 09 Month 01 Day
Anticipated trial start date
2016 Year 09 Month 06 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 05 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031667

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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