UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022944 |
|---|---|
| Receipt number | 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 17:20:08 |
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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
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
tmorishita@fukuoka-u.ac.jp
Public contact
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
tmorishita@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Rehabilitation department
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026437
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