UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059668 |
|---|---|
| Receipt number | R000068252 |
| Scientific Title | Development of an Assessment Scale for Chopstick Skills in Stroke Patients |
| Date of disclosure of the study information | 2025/11/06 |
| Last modified on | 2025/11/06 17:27:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of an Assessment Scale for Chopstick Skills in Stroke Patients
Acronym
Development of an Assessment Scale for Chopstick Skills in Stroke Patients
Scientific Title
Development of an Assessment Scale for Chopstick Skills in Stroke Patients
Scientific Title:Acronym
Development of an Assessment Scale for Chopstick Skills in Stroke Patients
Region
| Japan |
Condition
Condition
Stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the reliability of the assessment scale for chopstick skills
To clarify the functional difficulty level of chopstick use with the paralyzed hand in stroke patients.
To clarify the changes in scores using the assessment scale for chopstick skills
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The score of the assessment scale for chopstick skills
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
Stroke patients admitted for the treatment of initial cerebral infarction or cerebral hemorrhage and undergoing rehabilitation.
Patients with a consciousness level of E4V4M6 or higher on the Glasgow Coma Scale (GCS).
Patients who can understand verbal instructions.
Key exclusion criteria
Individuals with a GCS score of E3 or M5 or lower; those who cannot understand verbal instructions; those with a history of stroke; and those with limited range of motion in the affected upper limb.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Abe |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of rehabilitation
Zip code
241-0811
Address
1197-1 Yasashicho , Asahi-ku , Yokohama , 241-0811 , Japan
TEL
045-366-1111
112a21003@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoto |
| Middle name | |
| Last name | Abe |
Organization
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Division name
Department of rehabilitation
Zip code
241-0811
Address
1197-1 Yasashicho , Asahi-ku , Yokohama , 241-0811 , Japan
TEL
045-366-1111
Homepage URL
112a21003@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine, Yokohama City Seibu Hospital
Institute
Department
Personal name
Abe Naoto
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Kasei University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine Ethics Review Committee
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki-shi, Kanagawa, 216-0015, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-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
| 2025 | Year | 11 | Month | 06 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cohort Study
Patients admitted to our hospital for stroke treatment and referred for rehabilitation will be informed about the study and asked for their informed consent. Those who provide consent will be recruited.
The measurement items include physical and mental functions and chopstick skills etc.
Management information
Registered date
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068252
