UMIN-CTR Clinical Trial

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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