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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036824
Receipt No. R000041949
Scientific Title Study of practice methods for writing skill improvement in non-dominant hand: Randomized controlled trial
Date of disclosure of the study information 2019/06/01
Last modified on 2019/05/22

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Basic information
Public title Study of practice methods for writing skill improvement in non-dominant hand
Acronym Study of practice methods for writing skill improvement in non-dominant hand
Scientific Title Study of practice methods for writing skill improvement in non-dominant hand: Randomized controlled trial
Scientific Title:Acronym Study of practice methods for writing skill improvement in non-dominant hand: Randomized controlled trial
Region
Japan

Condition
Condition Healthy people
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of dominant hand exchange practice on writing skill among writing practice group, instrument practice group and control group.
To clarify the time required for writing ability improvement and the factors related to writing ability improvement.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of change before and after intervention of character recognition rate by Optical Character Recognition (OCR) method.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Writing practice group: Practice writing by trace writing. 20 minutes a day for 10 days.
Interventions/Control_2 Instrument practice group: Practice using a training instrument that improves finger movement. 20 minutes a day for 10 days.
Interventions/Control_3 Control group: No practice.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria Left-handed person.
People with muscle weakness in the right upper limb (less than 4 with Manual Muscle Testing).
People with limited range of motion in the right upper limb.
People with sensory disorder and abnormal sensation in the right upper limb.
People who have otherwise been determined to be ineligible as a subject by the principal investigator.
Target sample size 75

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Mutai
Organization Shinshu University
Division name Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code 390-8621
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2405
Email hitmutai@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Mutai
Organization Shinshu University
Division name Division of occupational therapy, School of health sciences, Faculty of Medicine
Zip code 390-8621
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2405
Homepage URL
Email hitmutai@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University
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 Shinshu University
Address 3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel 0263-37-2572
Email mdrinri@shinshu-u.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
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 06 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
2019 Year 05 Month 22 Day
Last modified on
2019 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041949

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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