UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061378 |
|---|---|
| Receipt number | R000070123 |
| Scientific Title | Development of a Three-Dimensional Quantitative Assessment Method for Finger Position in Patients with Post-Stroke Hemiparesis: Examination of Reliability, Validity, and Responsiveness |
| Date of disclosure of the study information | 2026/04/27 |
| Last modified on | 2026/04/26 16:44:54 |
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Basic information
Public title
A Study of a New Three-Dimensional Method to Measure Hand and Finger Movements After Stroke
Acronym
3D Finger Study
Scientific Title
Development of a Three-Dimensional Quantitative Assessment Method for Finger Position in Patients with Post-Stroke Hemiparesis: Examination of Reliability, Validity, and Responsiveness
Scientific Title:Acronym
3D-FINGER Study
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop an assessment method using the extended version of Google MediaPipe Hands (GMH-D) to quantitatively evaluate three-dimensional finger positions in patients with post-stroke motor paralysis, and to examine its reliability, validity, and responsiveness.
Basic objectives2
Others
Basic objectives -Others
Development and validation of a three-dimensional assessment method for finger position in patients with post-stroke hemiparesis
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Three-dimensional coordinates of the fingers, assessed at baseline and after 3-4 weeks of intervention for responsiveness evaluation
Key secondary outcomes
Fugl-Meyer Assessment upper extremity
modified Ashworth scale
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
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older. For the prospective cohort study assessing responsiveness, only first-ever stroke patients will be included.
2. Unilateral cerebral lesion confirmed by imaging findings or physician diagnosis/clinical records.
3. Ability to position the hand so that the fingertips can be captured by the camera during assessment.
Key exclusion criteria
1.Severe finger contracture or spasticity affecting the hand/fingers.
2.Difficulty in communication due to aphasia or impaired consciousness.
3.Severe higher brain dysfunction that interferes with assessment procedures.
4.Severe visual or hearing impairment.
5.Severe psychiatric disorders such as depression or schizophrenia.
6.Contraindications to exercise therapy, including:
a. Severe cardiovascular disease, such as unstable angina, recent myocardial infarction, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, severe aortic stenosis, active myocarditis, or endocarditis.
b. Uncontrolled hypertension.
c. Acute systemic illness or fever.
d. Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension.
e. Severe hepatic or renal dysfunction.
f. Severe orthopedic disorders interfering with exercise.
g. Severe cognitive impairment or severe psychiatric disorders.
h. Other metabolic disorders (e.g., acute thyroiditis).
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Michiyuki |
| Middle name | |
| Last name | Kawakami |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5843-6169
michiyukikawakami@a3.keio.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Dogan |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5843-6169
Homepage URL
dogan.m@keio.jp
Sponsor or person
Institute
Keio University School
Institute
Department
Personal name
Michiyuki Kawakami
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Research Ethics Committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2026 | Year | 04 | Month | 27 | 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
| 2026 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was approved by the Research Ethics Committee of Keio University School of Medicine and registered in UMIN-CTR prior to study initiation.
Management information
Registered date
| 2026 | Year | 04 | Month | 26 | Day |
Last modified on
| 2026 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070123
