UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013721 |
|---|---|
| Receipt number | R000016020 |
| Scientific Title | Clinical application of robotic wear (Curara) for patients with neuromuscular disorders |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2019/04/22 18:06:25 |
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Basic information
Public title
Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Acronym
Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Scientific Title
Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Scientific Title:Acronym
Clinical application of robotic wear (Curara) for patients with neuromuscular disorders
Region
| Japan |
Condition
Condition
spinocerebellar degeneration, multiple system atrophy, spinal muscular atrophy (including spinal bulbar muscular atrophy), muscular dystrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assist the patients with neuromuscular disorders to walk
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) interactive torque (joint torque)
2) angular velocity (rad/s) & angular acceleration (rad/s2)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
to assess the efficacy of robotic wear (Curara) on walking
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
adult patients with the conditions described above who are able to stand and walk independently
Key exclusion criteria
patients with the age under 20 years old, or patients who are not able to stand or walk independently, even if they have the conditions decribed above
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Shinshu University
Division name
School of Medicine, Department of Brain Disease Research
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto 390-8621
TEL
0263-37-2673
kyoshida@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Shinshu University
Division name
School of Medicine, Department of Brain Disease Research
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto 390-8621
TEL
0263-37-2673
Homepage URL
kyoshida@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine, Department of Brain Disease Research
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Sceience and Technology
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
the Committee for Medical Ethics of Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto 390-8621
Tel
0263-37-2572
mdrinri@shinshu-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
信州大学医学部附属病院（長野県）、信州大学医学部旭総合研究棟（長野県）、信州大学大学院生命機能・ファイバー工学専攻感性システム工学講座（長野県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
| 2014 | Year | 04 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was completed by the end of March, 2019, and followed by the clinical research named as "Rehabilitation trial using robotec wear curara for patients with cerebrovascular and neurodegenerative diseases (part 1: cerebrovascular disease; part 2: spinocerebellar degeneration)". This trials are sponsored by Japan Agency for Medical Research and Development (AMED) and have started on October 3, 2018. Two different clinical trials are now on going (cerebrovascular disease: jRCTs032180163; spinocerebellar degeneration: jRCTs032180164).
Management information
Registered date
| 2014 | Year | 04 | Month | 15 | Day |
Last modified on
| 2019 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016020
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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