UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054591 |
|---|---|
| Receipt number | R000061737 |
| Scientific Title | Calculation of the Minimal clinically important difference in physical function evaluation for spinal muscular atrophy |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2025/01/08 12:25:45 |
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Basic information
Public title
Calculation of the Minimal clinically important difference in physical function evaluation for spinal muscular atrophy
Acronym
Calculation of the Minimal clinically important difference in physical function evaluation for spinal muscular atrophy
Scientific Title
Calculation of the Minimal clinically important difference in physical function evaluation for spinal muscular atrophy
Scientific Title:Acronym
Calculation of the Minimal clinically important difference in physical function evaluation for spinal muscular atrophy
Region
| Japan |
Condition
Condition
spinal muscular atrophy
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the minimal clinically important difference (MCID) in physical function assessment in spinal muscular atrophy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Hammersmith, Functional Motor Scale Expanded (HFMSE)
Key secondary outcomes
Grip strength, manual muscle strength test, Revised Upper Limb Module (RULM),
Base
Study type
Others,meta-analysis etc
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
| 3 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who underwent rehabilitation and physical function evaluation at our hospital
Key exclusion criteria
Patients for whom functional evaluation could not be performed
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hara |
| Middle name | |
| Last name | Takatoshi |
Organization
National Center of Neurology and Psychiatry, NCNP
Division name
Department of Physical Rehabilitation
Zip code
1878551
Address
4-1-1 Ogawahigasityo Kodairashi Tokyo
TEL
042-341-2711
t_hara1019@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Hara |
| Middle name | |
| Last name | Takatoshi |
Organization
National Center of Neurology and Psychiatry, NCNP
Division name
Department of Physical Rehabilitation
Zip code
2110063
Address
4-1-1 Ogawahigasityo Kodairashi Tokyo
TEL
042-341-2711
Homepage URL
t_hara1019@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry, NCNP
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry, NCNP
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
National Center of Neurology and Psychiatry, NCNP
Address
4-1-1Ogawahigashityo Kodairashi tokyo
Tel
0423412711
t_hara1019@ncnp.go.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 | 06 | 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
26
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061737
