UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056906 |
|---|---|
| Receipt number | R000065039 |
| Scientific Title | Objective Evaluation of Upper Limb Coordination Function Using a Tablet PC |
| Date of disclosure of the study information | 2025/02/03 |
| Last modified on | 2025/02/02 16:08:00 |
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Basic information
Public title
Measuring Hand and Arm Movements Using a Tablet PC
Acronym
Tablet Upper Limb Test
Scientific Title
Objective Evaluation of Upper Limb Coordination Function Using a Tablet PC
Scientific Title:Acronym
Tablet-Based Upper Limb Coordination Evaluation
Region
| Japan |
Condition
Condition
Adults aged 20 years or older without upper limb coordination dysfunction (including healthy individuals) and adults aged 20 years or older with upper limb coordination dysfunction.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate upper limb coordination function using the Trace Coder and to examine its potential for objectively assessing the presence and severity of upper limb coordination dysfunction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Deviation between the shapes displayed on the tablet PC and the values indicated by the participant using a stylus.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 years or older who have received a thorough explanation of the study, fully understood its content, and provided written informed consent of their own free will.
Key exclusion criteria
Individuals unable to maintain a seated position.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
TEL
+81-562-93-2167
otaka119@mac.com
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Matsuura |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
TEL
+81-562-93-2167
Homepage URL
hero850411@yahoo.co.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Grants from the Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi 470-1192, JAPAN
Tel
+81-562-93-2865
f-irb@fujita-hu.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
HM22-414
Org. issuing International ID_1
Fujita Health University Medical Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 03 | 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
103
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 23 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Secondary Outcome Measures:
-Age and sex of the participants
-For participants who are patients: Diagnosis, number of days since onset, and results of upper limb function tests (STEF, FMA) conducted separately from this study
-Assessment of handedness using handedness tests (Edinburgh Handedness Inventory, Flanders Handedness Test)
Management information
Registered date
| 2025 | Year | 02 | Month | 02 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065039
