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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027288
Receipt No. 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

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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
Email 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
Email goto.kyo.411@outlook.jp

Sponsor
Institute fukuoka university hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031269

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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