UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055264 |
|---|---|
| Receipt number | R000063148 |
| Scientific Title | Creation of a Japanese version of "The Motor Activity Log adapted for hospital (MAL-hospital)," a. method for evaluating upper limb motor function after stroke, and examination of its reliability and validity. |
| Date of disclosure of the study information | 2024/08/19 |
| Last modified on | 2024/08/16 22:52:03 |
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Basic information
Public title
Creation of a Japanese version of "The Motor Activity Log adapted for hospital (MAL-hospital)," a. method for evaluating upper limb motor function after stroke, and examination of its reliability and validity.
Acronym
Creation of a Japanese version of "The Motor Activity Log adapted for hospital (MAL-hospital)," a. method for evaluating upper limb motor function after stroke, and examination of its reliability and validity.
Scientific Title
Creation of a Japanese version of "The Motor Activity Log adapted for hospital (MAL-hospital)," a. method for evaluating upper limb motor function after stroke, and examination of its reliability and validity.
Scientific Title:Acronym
Creation of a Japanese version of "The Motor Activity Log adapted for hospital (MAL-hospital)," a. method for evaluating upper limb motor function after stroke, and examination of its reliability and validity.
Region
| Japan |
Condition
Condition
Those presenting with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop a Japanese version of The Motor Activity Log adapted for hospital (MAL-hospital) for use in the hospital and during hospitalization, and to examine its reliability and validity in subjects who had suffered a stroke. The purpose of this study is to examine the reliability and validity of the MAL-hospital.
Basic objectives2
Others
Basic objectives -Others
The significance of this study is to understand the use of the paralyzed upper limb in the hospital and during hospitalization by creating the MAL-hospital. In addition, by investigating the relationship with other physical function and activity function assessments, it may help to clarify the relationship between the use of the paralyzed upper limb and life in the hospital and during the hospitalization period. This may help us to consider appropriate intervention strategies for rehabilitation, such as encouraging the use of the upper limb in the hospital and during hospitalization, and how to interact with the subject according to his/her living conditions. Therefore, this study is appropriate because of its potential to benefit both subjects and therapists.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Motor Activity Log adapted for hospital Japanese version draft, Motor Activity Log-14 (MAL-14) ,Brunnstrom Stage, Fugl-Meyer Assessment Upper Extremity Items (FMA-UE), ability test of 5 movements The following is a list of the five movement ability tests.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
To test the reliability and validity of the trial on subjects who have suffered a stroke
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stroke, male or female, aged 20-90 years, who are able to make decisions and give written consent to participate in the study, and who have the verbal ability to perform the above assessments.
Key exclusion criteria
Those who do not meet the selection criteria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kawakami |
| Middle name | |
| Last name | daichi |
Organization
Senri Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
5620032
Address
4-6-1 Onoharanishi, Mino-shi, Osaka, Japan
TEL
0727263300
k.d.9116@docomo.ne.jp
Public contact
Name of contact person
| 1st name | kawakami |
| Middle name | |
| Last name | daichi |
Organization
Senri Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
5620032
Address
4-6-1 Onoharanishi, Mino-shi, Osaka, Japan
TEL
0727263300
Homepage URL
k.d.9116@docomo.ne.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
without
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Senri Rehabilitation Hospital
Address
4-6-1 Onoharanishi, Mino-shi, Osaka, Japan
Tel
0727263300
sr24657d@st.omu.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
| 2024 | Year | 08 | Month | 19 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | 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
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063148
