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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048058
Receipt No. R000054772
Scientific Title Effect of combining peripheral sensory nerve electrical stimulation and practice on improving the writing ability of the non-dominant hand: A randomized controlled trial Part2
Date of disclosure of the study information 2022/06/14
Last modified on 2022/06/14

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Basic information
Public title A study examining the effect of electrical stimulation of sensory nerves of the arm on exercises to improve the writing ability of the non-dominant hand
Acronym A study examining the effect of electrical stimulation of sensory nerves of the arm on exercises to improve the writing ability of the non-dominant hand
Scientific Title Effect of combining peripheral sensory nerve electrical stimulation and practice on improving the writing ability of the non-dominant hand: A randomized controlled trial Part2
Scientific Title:Acronym Effect of combining peripheral sensory nerve electrical stimulation and practice on improving the writing ability of the non-dominant hand: A randomized controlled trial Part2
Region
Japan

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

Objectives
Narrative objectives1 To compare the effect of combining peripheral sensory nerve electrical stimulation with writing practice on the writing ability of the non-dominant hand among the PES, non-PES, and control groups.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Global legibility scales
Key secondary outcomes Character recognition rate by Optical Character Recognition (OCR) method
Time to transcribe characters

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 PES group: The participants are given 40 minutes of electrical stimulation before practice, followed by 20 minutes of writing practice while receiving electrical stimulation. The practice period is 5 days.
Interventions/Control_2 Practice writing letters for 20 minutes without electrical stimulation. The practice period is 5 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 Participants who gave voluntary written informed consent after receiving an adequate explanation regarding their participation in the study.
Key exclusion criteria Individuals with the following conditions were excluded:
-sites of hemostatic tissue
-areas with moderate or higher edema
-acute (painful) illness of unknown cause
-heart problems
-high bleeding diathesis
-malignant tumors
-pregnancy
-skin damage or inflamed areas
-febrile illness
-infectious diseases
-venous distended skin surface
-metal or plastic parts embedded in their body
- at risk of vascular disorders such as thrombosis, venous thrombosis, and varicose veins
Target sample size 60

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 0263372405
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 0263372405
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
2022 Year 06 Month 14 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
2022 Year 05 Month 12 Day
Date of IRB
2022 Year 05 Month 19 Day
Anticipated trial start date
2022 Year 07 Month 04 Day
Last follow-up date
2024 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
2022 Year 06 Month 14 Day
Last modified on
2022 Year 06 Month 14 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054772

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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