UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054910 |
|---|---|
| Receipt number | R000062147 |
| Scientific Title | Reliability and validity of the Japanese version of the Confidence in Arm and Hand Movement scale |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2025/02/19 12:07:58 |
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Basic information
Public title
Reliability and validity of the Japanese version of the Confidence in Arm and Hand Movement scale
Acronym
Reliability and validity of the Japanese version of the CAHM scale
Scientific Title
Reliability and validity of the Japanese version of the Confidence in Arm and Hand Movement scale
Scientific Title:Acronym
Reliability and validity of the Japanese version of the CAHM scale
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reliability and validity of the Japanese version of the Confidence in Arm and Hand Movement scale in patients with stroke.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validity:
correlation coefficients between the scores of the Japanese version of the Confidence in Arm and Hand Movement scale (CAHM), the Motor Activity Log-14 (MAL-14), and the Fugl-Meyer Assessment (FMA).
Reliability:
intraclass Correlation Coefficient (ICC) for the scores of the CAHM from the first and second assessments.
Key secondary outcomes
No applicablele
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
This study will include participants who provide written informed consent, are at least 20 years old, have upper limb dysfunction due to cerebrovascular disorders, are currently undergoing rehabilitation, and anticipate using their upper limbs in daily life.
Key exclusion criteria
The study will exclude participants who experience severe upper limb pain, severe higher brain dysfunction, those requiring assistance in providing informed consent, individuals deemed unsuitable by their attending physician, and those needing assistance with reading or writing Japanese.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Nagayoshi |
Organization
Tamakyuryo Rehabilitation Hospital
Division name
Rehabilitation
Zip code
194-0202
Address
1491, Shimooyamadamachi, Machida, Tokyo, JAPAN
TEL
0427-97-1650
nagayoshi.takao@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Nagayoshi |
Organization
Tamakyuryo Rehabilitation Hospital
Division name
Rehabilitation
Zip code
194-0202
Address
1491, Shimooyamadamachi, Machida, Tokyo, JAPAN
TEL
0427-97-1650
Homepage URL
nagayoshi.takao@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
Kitasato University
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
Tamakyuryo Rehabilitation Hospital
Address
1491, Shimooyamadamachi, Machida, Tokyo, JAPAN
Tel
0427-97-1650
nagayoshi.takao@st.kitasato-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
| 2024 | Year | 07 | Month | 10 | 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 | 03 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All items related to concurrent validity (Japanese versions of CAHM, FMA, and MAL) will be measured on the same day. The internal consistency of the Japanese version of the CAHM will be verified using Cronbach's alpha coefficient. The measurement of test-retest reliability will be conducted twice in total. The interval between the first and second measurements will be two weeks for outpatients and one week for inpatients. To prevent patient confusion, measurements will not be conducted immediately after admission.
Management information
Registered date
| 2024 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062147
