UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048058 |
|---|---|
| Receipt number | 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 | 2022/12/14 11:06:05 |
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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
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
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
Shinshu University
Address
3-1-1, Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
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
Open public recruiting
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 | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054772
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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