UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054903 |
|---|---|
| Receipt number | R000062725 |
| Scientific Title | Research on Novel Rehabilitation Therapies for Neuromuscular Diseases |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2024/09/21 09:08:41 |
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Basic information
Public title
Research on Novel Rehabilitation Therapies for Neuromuscular Diseases
Acronym
Research on Novel Rehabilitation Therapies for Neuromuscular Diseases
Scientific Title
Research on Novel Rehabilitation Therapies for Neuromuscular Diseases
Scientific Title:Acronym
Research on Novel Rehabilitation Therapies for Neuromuscular Diseases
Region
| Japan |
Condition
Condition
Neuromuscular Diseases
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Research on New Rehabilitation Therapies for Neuromuscular Diseases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
HAL (Hybrid Assitive Limb)
Interventions/Control_2
no HAL
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
ALS, GNE myopathy, inclusion body myositis, etc.
Key exclusion criteria
(1) Patients with other serious comorbid conditions deemed inappropriate for the study by the researchers
(2) Patients deemed unsuitable for enrollment by the principal investigator or sub-investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku University
Division name
Department of Rehabilitation Medicine
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7000
naoki.suzuki.e3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tohoku University
Division name
Department of Rehabilitation Medicine
Zip code
980-8574
Address
Seiryo-machi 1-1, Sendai
TEL
022-717-7000
Homepage URL
naoki.suzuki.e3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 31 | 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
Management information
Registered date
| 2024 | Year | 07 | Month | 06 | Day |
Last modified on
| 2024 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062725
