UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041075 |
|---|---|
| Receipt number | R000046887 |
| Scientific Title | Research of fine motor function of finger in patients with neuromuscular diseases |
| Date of disclosure of the study information | 2020/07/13 |
| Last modified on | 2020/07/14 07:06:41 |
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Basic information
Public title
Research of fine motor function of finger in patients with neuromuscular diseases
Acronym
Research of fine motor function of finger in patients with neuromuscular diseases
Scientific Title
Research of fine motor function of finger in patients with neuromuscular diseases
Scientific Title:Acronym
Research of fine motor function of finger in patients with neuromuscular diseases
Region
| Japan |
Condition
Condition
neuromuscular diseases
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether tapping and sweeping movement have the efficacy as evaluation method of motor function in advanced patients with neuromuscular diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the number of tapping and sweeping movement for 30 second on tablet from the baseline to 6 month after and one year after.
Key secondary outcomes
Change of the number of tapping and sweeping movement of last 10 second period for 30 second on tablet from the baseline to 6 month after and one year after.
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
patients with neuromuscular diseases such as spinal muscular atrophy and muscular dystrophy, who can take a posture for tapping and sweeping of fingers
Key exclusion criteria
patients with neuromuscular diseases who can not take a posture for tapping and sweeping of fingers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Saito |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Department of Neurology
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka
TEL
06-6853-2001
saito.toshio.cq@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Saito |
Organization
National Hospital Organization Osaka Toneyama Medical Center
Division name
Department of Neurology
Zip code
560-8552
Address
5-1-1 Toneyama, Toyonaka, Osaka
TEL
06-6853-2001
Homepage URL
saito.toshio.cq@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Research, National Hospital Organization Osaka Toneyama Medical Center
Address
5-1-1 Toneyama, Toyonaka, Osaka
Tel
06-6853-2001
410-chiken@mail.hosp.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
| 2020 | Year | 07 | Month | 13 | 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 | 05 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 13 | 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
The number of tapping and sweeping of fingers movement for 30 second on tablet (5 to 10 period)
Research object code, birth year and month, gender, disease, Diagnostic basis, medical history
Clinical information:
Height, body weight, motor function (ambulant, wheel chair, bed ridden, etc)
Respiratory function (voluntary, non-invasive ventilation, invasive ventilation, etc)
Nutritional method (per oral, tube feeding, gastrostomy tube, etc)
Other complication (heart failure, etc), medication
Evaluation of rehabilitation:
Manual muscle test(MMT), Hammersmith Functional Motor Scale-Expanded(HFMSE)(for SMA), revised upper limb mudule(RULM)(for SMA), etc
Clinical laboratory test:
Blood analysis, blood chemistry,
Chest x-ray, spine x-ray, echocardiography, electrocardiography, respiratory function (VC, %VC, etc)
Management information
Registered date
| 2020 | Year | 07 | Month | 12 | Day |
Last modified on
| 2020 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046887
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
