UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000022944
Receipt No. R000026437
Scientific Title Development of active exercise auxiliary equipment for robot suit HAL Single-Joint type
Date of disclosure of the study information 2016/07/03
Last modified on 2019/03/18 (Ver. 9)

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Basic information
Public title Development of active exercise auxiliary equipment for robot suit HAL Single-Joint type
Acronym Development of auxiliary equipment for HAL-SJ
Scientific Title Development of active exercise auxiliary equipment for robot suit HAL Single-Joint type
Scientific Title:Acronym Development of auxiliary equipment for HAL-SJ
Region
Japan

Condition
Condition Osteoarthritis of the knee
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We develop auxiliary equipment to use an HAL Single-Joint type more effectively
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase

Assessment
Primary outcomes Presence of a wound with a machinery and significant fatigue / pain
Key secondary outcomes Age, sex, height, weight, range of motion, muscular strength, a feeling of use, ADL score

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Using an HAL Single-Joint type and auxiliary equipment, we bend and stretch a knee.
We aim for each around 30 minutes three times a week and intervene.
We sentence you to two weeks for an intervention period of each subject.
Interventions/Control_2 Movement similar to that of the HAL group is carried out without mounting the HAL. The exercise frequency and duration are carried out in the same manner as in the HAL group.
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

Not applicable
Gender Male and Female
Key inclusion criteria The patient operated on by a diagnosis in this hospital with gonarthrosis
Key exclusion criteria The patient having CNS disease / intractable disease / mental disorder
When we compete with other clinical tests
The patient who admitted that a doctor was inadequate
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name Naoya
Middle name
Last name Kotani
Organization Fukuoka University Hospital
Division name Rehabilitation department
Zip code 814-0180
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL +81928011011
Email tmorishita@fukuoka-u.ac.jp

Public contact
1st name of contact person
1st name Naoya
Middle name
Last name Kotani
Organization Fukuoka University Hospital
Division name Rehabilitation department
Zip code 814-0180
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka
TEL +81928011011
Homepage URL
Email tmorishita@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Hospital
Rehabilitation department
Institute
Department

Funding Source
Organization CYBERDYNE Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor CYBERDYNE Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Fukuoka university hospital
Address Nanakuma 7-45-1, Jonan ward
Tel +81928011011
Email hayakawa@adm.fukuoka-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 福岡大学病院（福岡県）

Other administrative information
Date of disclosure of the study information
2016 Year 07 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 22
Results 
Both groups showed significant improvement between postoperative days 5 and 10 in all outcome measures. Improvements in active ROM (p<0.01), passive ROM (p<0.01), muscle strength (p<0.01), and pain (p<0.01) were significantly greater in the HAL-SJ group than in the CPT group. Long-term outcomes were also significantly better in the HAL-SJ group.
Results date posted
2019 Year 03 Month 18 Day
Results Delayed
Delay expected
Results Delay Reason Peer review delay
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
2016 Year 06 Month 22 Day
Date of IRB
2016 Year 04 Month 20 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 30 Day
Date trial data considered complete
2018 Year 09 Month 30 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 06 Month 29 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026437