UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044218
Receipt number R000050496
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
Date of disclosure of the study information 2021/05/15
Last modified on 2023/02/28 17:49:27

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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

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

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: Practice writing characters with electrical stimulation: 20 minutes a day for 10 days.

Interventions/Control_2

Non-PES group: Practice writing characters without electrical stimulation: 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.
Individuals with the following conditions were excluded:
-muscle weakness in the right upper limb (less than 4 with Manual Muscle Testing).
-limited range of motion in the right upper limb.
-sensory disorder and abnormal sensation in the right upper limb.
-use a pacemaker.
-have otherwise been determined to be ineligible as a subject by the principal investigator.
-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
-have otherwise been determined to be ineligible as a subject by the principal investigator.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Mutai
Middle name
Last name Hitoshi

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 Mutai
Middle name
Last name Hitoshi

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 or person

Institute

Shinshu University

Institute

Department

Personal name



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

Ethics Committee of the Shinshu University School of Medicine

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

2021 Year 05 Month 15 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

27

Results

Nine subjects were in the PES group, nine subjects in the non-PES group, and nine subjects in the target group. The writing ability was evaluated by letter recognition rate, subjective evaluation, and writing speed, and no significant difference was found between the PES and non-PES groups in the improvement of writing ability, but significant differences were found between the PES group and the subject group in letter recognition rate and subjective evaluation.

Results date posted

2022 Year 03 Month 22 Day

Results Delayed

Delay expected

Results Delay Reason

Paper not accepted

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

2021 Year 05 Month 14 Day

Date of IRB

2021 Year 05 Month 14 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2021 Year 11 Month 26 Day

Date of closure to data entry

2021 Year 11 Month 30 Day

Date trial data considered complete

2021 Year 11 Month 30 Day

Date analysis concluded

2023 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2021 Year 05 Month 15 Day

Last modified on

2023 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050496


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name