UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036563 |
|---|---|
| Receipt number | R000041657 |
| Scientific Title | Training with Hybrid Assistive Limb for patients with neurodegenerative disease |
| Date of disclosure of the study information | 2019/04/21 |
| Last modified on | 2022/10/23 12:42:12 |
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Basic information
Public title
Training with Hybrid Assistive Limb for patients with neurodegenerative disease
Acronym
Training with Hybrid Assistive Limb for patients with neurodegenerative disease
Scientific Title
Training with Hybrid Assistive Limb for patients with neurodegenerative disease
Scientific Title:Acronym
Training with Hybrid Assistive Limb for patients with neurodegenerative disease
Region
| Japan |
Condition
Condition
neurodegenerative disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Hybrid assistive limb (HAL) for the patients with neurodegenerative disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
2 minutes walk, 10 m walk
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
training with HAL
Interventions/Control_2
training without 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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with neurodegenerative disease who fulfill the criteria.
Key exclusion criteria
Less than 20-y-o, demented patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Kano |
Organization
Toho University Omori Medical Center
Division name
Neurology
Zip code
1438541
Address
6-11-1 Omorinishi Ota-ku Tokyo
TEL
03-3762-4151
osamu.kano@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Kano |
Organization
Toho University Omori Medical Center
Division name
Neurology
Zip code
1438541
Address
6-11-1 Omorinishi Ota-ku Tokyo
TEL
03-3762-4151
Homepage URL
osamu.kano@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Neurology, Toho University Omori Medical Center
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
Toho University Omori Medical Center
Address
6-11-1 Omorinishi Ota-ku Tokyo
Tel
03-3762-4151
osamu.kano@med.toho-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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 21 | 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
| 2018 | Year | 12 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2019 | Year | 04 | Month | 21 | Day |
Last modified on
| 2022 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041657
| 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 |
