UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056693 |
|---|---|
| Receipt number | R000064805 |
| Scientific Title | Verification of the reliability and validity of the Action Research Arm Test. |
| Date of disclosure of the study information | 2025/01/12 |
| Last modified on | 2025/01/12 16:13:31 |
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Basic information
Public title
Validation of the assessment of upper limb function in patients with stroke.
Acronym
Validation of the assessment of upper limb function in patients with stroke.
Scientific Title
Verification of the reliability and validity of the Action Research Arm Test.
Scientific Title:Acronym
Verification of the reliability and validity of the Action Research Arm Test.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the reliability and validity of the Action Research Arm Test, an upper extremity functional assessment performed on hemiplegic patients after stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Action Research Arm Test
Key secondary outcomes
Fugl-Meyer Assessment of the Upper Extremity
Jikei Assessment Scale for Motor Impairment in Daily Living
The Southampton Hand Assessment Procedure
Grip
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Those with hemiplegia after stroke
Key exclusion criteria
Those with impaired consciousness, cognitive dysfunction, or mental disorder that limits their ability to perform and understand the tests and measurements.
Those with motor paralysis of the upper limbs on both sides.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Abo |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
0334331111
abo@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Sakamoto |
Organization
The Jikei University Graduate School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
1058471
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
03-3433-1111
Homepage URL
daigo.0612@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Human Subjects Committee of the Jikei University School of Medicine
Address
3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo, Japan
Tel
0334331111
rinri@jikei.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
東京慈恵会医科大学附属病院（東京） / The Jikei University Hospital (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is ongoing and data is being accumulated.
Management information
Registered date
| 2025 | Year | 01 | Month | 12 | Day |
Last modified on
| 2025 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064805
