UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033245 |
|---|---|
| Receipt number | R000037904 |
| Scientific Title | Comprehensive study for rehabilitation with robot suits and the three demensional motion analysis system. |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2023/10/17 17:53:57 |
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Basic information
Public title
Comprehensive study for rehabilitation with robot suits and the three demensional motion analysis system.
Acronym
Comprehensive rehabilitation study with robot suits
Scientific Title
Comprehensive study for rehabilitation with robot suits and the three demensional motion analysis system.
Scientific Title:Acronym
Comprehensive rehabilitation study with robot suits
Region
| Japan |
Condition
Condition
Spinal cord injury, stroke, neuro-muscular disease,disuse syndrome
Classification by specialty
| Medicine in general | Neurology | Surgery in general |
| Orthopedics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To exmaine the safety and effectiveness of rehabilitation with robot suits HAL for the conditions such as spinal cord injury, stroke, neuro-muscular disease,and disuse syndrome.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Basic mobility and gait function examined by the three dementional motional analysis for the baseline, 2weeks after, 4weeks after, and 8weeks after the intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Other |
Interventions/Control_1
rehabilitation with robot suits HAL
Frequency of intervention:1-10 times (as needed)
Interventions/Control_2
General rehabilitation
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
| 15 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with the weakness of lower limb(s) due to spinal cord injury, stroke, neuro-muscular disease, or disuse syndrome.
Key exclusion criteria
Patients who cannot engage in physical exercises due to other diseases or patients who cannot follow the exercise instruction due to cognitive impairments.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Ogata |
Organization
The University of Tokyo Hospital
Division name
Rehabilitation Center
Zip code
113-8655
Address
Hongo 7-3-1 Bunkyo-ku Hongo Tokyo
TEL
03-5800-8680
ogatat-reh@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hasegawa |
| Middle name | |
| Last name | Masato |
Organization
The University of Tokyo Hospital
Division name
Rehabilitation Center
Zip code
113-8655
Address
Hongo 7-3-1 Bunkyo-ku Hongo Tokyo
TEL
03-5800-8680
Homepage URL
hasegawam-reh@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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
The University of Tokyo, Graduate School of Medicine and Faculty of Medicine, Office for Human Research Studies
Address
Hongo 7-3-1 Bunkyo-ku Hongo Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2018 | Year | 07 | Month | 04 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037904
| 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 |
