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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017623 |
Receipt No. | R000020421 |
Scientific Title | Clinical application of robot suit HAL for joint disease |
Date of disclosure of the study information | 2015/05/19 |
Last modified on | 2018/05/06 |
Basic information | ||
Public title | Clinical application of robot suit HAL for joint disease | |
Acronym | Clinical application of robot suit HAL for joint disease | |
Scientific Title | Clinical application of robot suit HAL for joint disease | |
Scientific Title:Acronym | Clinical application of robot suit HAL for joint disease | |
Region |
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Condition | ||||
Condition | Joint disease (osteoarthritis and rheumatoid arthritis) | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety and efficacy after using robot suit HAL as rehabilitation for conservative or operative treatment of Joint disease (osteoarthritis and rheumatoid arthritis) in our hospital |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Safety (injury, dermatopathy, etc.)
Efficacy |
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 |
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Interventions/Control_1 | We performed walk exercise (10-20 mins/day, 3-5days/week) for 4 weeks using robot suit HAL as rehabilitation for conservative or operative treatment of joint disease (osteoarthritis and rheumatoid arthritis). | |
Interventions/Control_2 | We performed walk exercise as rehabilitation for conservative or operative treatment of joint disease (osteoarthritis and rheumatoid arthritis). | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | patients with joint disease (osteoarthritis and rheumatoid arthritis)under hospitalization for conservative or operative treatment | |||
Key exclusion criteria | 1. Patients with serious complications
(heart disease, liver disease, renal disease) 2. Patients with disease or injury of brain, spinal cord and muscle 3. Patients with malignant tumor or suspected to have it within five years before agreement day 4. Patients with pregnancy or suspected pregnancy 5. The patient who does not have ability for voluntary agreement 6. The patient that the acquisition of the written agreement is impossible 7. The patient who judged that the medical doctor was inappropriate |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Ibaraki Prefectural University of Health Sciences | ||||||
Division name | Center for Medical Sciences | ||||||
Zip code | |||||||
Address | 4669-2 Ami, Inashiki-gun, Ibaraki | ||||||
TEL | 029-888-4000 | ||||||
mutsuzaki@ipu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Ibaraki Prefectural University of Health Sciences | ||||||
Division name | Center for Medical Sciences | ||||||
Zip code | |||||||
Address | 4669-2 Ami, Inashiki-gun, Ibaraki | ||||||
TEL | 029-888-4000 | ||||||
Homepage URL | |||||||
mutsuzaki@ipu.ac.jp |
Sponsor | |
Institute | Ibaraki Prefectural University of Health Sciences |
Institute | |
Department |
Funding Source | |
Organization | Ibaraki Prefectural University of Health Sciences |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
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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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020421 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |