UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027288 |
|---|---|
| Receipt number | R000031269 |
| Scientific Title | Effectiveness of the single-joint HAL robot suit for rehabilitation after orthopedic surgery |
| Date of disclosure of the study information | 2017/05/10 |
| Last modified on | 2019/03/18 17:48:18 |
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Basic information
Public title
Effectiveness of the single-joint HAL robot suit for rehabilitation after orthopedic surgery
Acronym
Effectiveness of the single-joint HALrobot suit
Scientific Title
Effectiveness of the single-joint HAL robot suit for rehabilitation after orthopedic surgery
Scientific Title:Acronym
Effectiveness of the single-joint HALrobot suit
Region
| Japan |
Condition
Condition
total knee arthoroplasty,high tibial osteotomy,medial patellofemoral ligament
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We aimed to evaluate the feasibility of robot,assisted rehabilitation using HAL-SL in the earlypostoperative state following knee surgeries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
range of motion(post operative day5)
Key secondary outcomes
visual analog scale(post operative day5)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
use HAL-SJ
Interventions/Control_2
do not use HAL-SJ
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
knee extension lag 10 and over,quad receps contraction,sitting posture
Key exclusion criteria
skin disease,pace maker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kyosuke |
| Middle name | |
| Last name | goto |
Organization
fukuoka university
Division name
rehabilitation
Zip code
814-0180
Address
7-45-1 nanakuma jyounan-ku,fukuoka
TEL
0928011011
goto.kyo.411@outlook.jp
Public contact
Name of contact person
| 1st name | kyosuke |
| Middle name | |
| Last name | goto |
Organization
fukuoka university hospital
Division name
department of rehabilitation
Zip code
814-0180
Address
7-45-1 nanakuma jyounan-ku,fukuoka
TEL
0928011011
Homepage URL
goto.kyo.411@outlook.jp
Sponsor or person
Institute
fukuoka university hospital
Institute
Department
Personal name
Funding Source
Organization
fukuoka university hospital
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
fukuoka university hospital
Address
7-45-1 nanakuma jyounan-ku,fukuoka
Tel
0928011011
goto.kyo.411@outlook.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 10 | 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
10
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
| 2017 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 09 | 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=R000031269
