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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

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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
Japan

Condition
Condition Joint disease (osteoarthritis and rheumatoid arthritis)
Classification by specialty
Orthopedics Rehabilitation medicine Adult
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
Device,equipment
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
50 years-old <=
Age-upper limit
90 years-old >=
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
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotaka Mutsuzaki
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
Email mutsuzaki@ipu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Mutsuzaki
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
Email 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
Email

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
2015 Year 05 Month 19 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 Completed
Date of protocol fixation
2015 Year 05 Month 18 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 19 Day
Last follow-up date
2018 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 05 Month 19 Day
Last modified on
2018 Year 05 Month 06 Day


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


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