UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical application of robot suit HAL for joint disease
Title of the study (Brief title)	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	Hirotaka Mutsuzaki
Organization	Ibaraki Prefectural University of Health Sciences
Division name	Center for Medical Sciences
Address	4669-2 Ami, Inashiki-gun, Ibaraki
TEL	029-888-4000
Email	mutsuzaki@ipu.ac.jp

Public contact
Name of contact person	Hirotaka Mutsuzaki
Organization	Ibaraki Prefectural University of Health Sciences
Division name	Center for Medical Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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