UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044029 |
|---|---|
| Receipt number | R000050276 |
| Scientific Title | Search for quantitative physiological indicators in patients with neuromuscular disease |
| Date of disclosure of the study information | 2021/04/24 |
| Last modified on | 2021/07/09 12:38:18 |
* 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
Search for quantitative physiological indicators as biomarkers that reflect movement disorders in patients with neuromuscular disease
Acronym
Search for quantitative physiological indicators in patients with neuromuscular disease
Scientific Title
Search for quantitative physiological indicators in patients with neuromuscular disease
Scientific Title:Acronym
Search for quantitative physiological indicators as biomarkers that reflect movement disorders in patients with neuromuscular disease
Region
| Japan |
Condition
Condition
neuromuscular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
If it becomes possible to quantify the degree of movement disorders in patients with neuromuscular diseases by physiological tests, it will be possible to more objectively determine the effects of treatment including medication. Therefore, we will search for physiological tests that correlate with movement disorders.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The Primary endpoint is the identification of physiological tests that correlate with movement disorders.
Key secondary outcomes
The Secondary endpoint is a secondary analysis of whether the combination provides a more accurate index when there are multiple correlated physiological tests.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) To exclude patients with internal disorders other than neuromuscular diseases
2) Considering the correlation between the motor function evaluation scale and the severity of the disease, if it is difficult to maintain a standing position, the floor effect of the scale reduces the correlation with the severity.
3) To obtain the validity of the test results
Key exclusion criteria
1) Patients who cannot get a definitive diagnosis after starting treatment at our hospital
2) Dementia patients
3) Others who are judged to be inappropriate by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | hashide |
| Middle name | |
| Last name | shusei |
Organization
national center of neurology and psychiatry
Division name
rehabilitation medicine
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2711
s-hashide@ncnp.go.jp
Public contact
Name of contact person
| 1st name | hashide |
| Middle name | |
| Last name | shusei |
Organization
national center of neurology and psychiatry
Division name
rehabilitation medicine
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
TEL
042-341-2711
Homepage URL
s-hashide@ncnp.go.jp
Sponsor or person
Institute
national center of neurology and psychiatry
Institute
Department
Personal name
Funding Source
Organization
national center of neurology and psychiatry
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
Clinical Trial Review Committee
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo, Japan
Tel
0423412711
rinri@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
| 2021 | Year | 04 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are accumulating test data for neuromuscular diseases at any time.
Management information
Registered date
| 2021 | Year | 04 | Month | 24 | Day |
Last modified on
| 2021 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050276
