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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032904
Receipt No. R000037519
Scientific Title The placement of around-knee neoprene sleeve may influence active repositioning of the knee joint
Date of disclosure of the study information 2018/06/18
Last modified on 2019/01/03

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Basic information
Public title The placement of around-knee neoprene sleeve may influence active repositioning of the knee joint
Acronym Knee sleeve and active repositioning of the knee joint
Scientific Title The placement of around-knee neoprene sleeve may influence active repositioning of the knee joint
Scientific Title:Acronym Knee sleeve and active repositioning of the knee joint
Region
Japan

Condition
Condition Healthy
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical experience support the idea that using a brace on the lower limb would affect proprioception, however previous studies show many inconsistencies. We aim to examine if placement of the neoprene sleeve and leg dominance would influence knee joint position sense under active repositioning. Participants will perform position sense tasks with both the dominant and non-dominant legs using an isokinetic dynamometer. Also, we will use a standing weight-bearing MRI to detect the pressure level of the applied external supports on the cross sectional areas. Our study would clarify what seems to be the most feasible and effective way, in regards to the placement of the neoprene sleeve to enhance proprioceptive acuity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes active proprioceptive target matching accuracy of the knee joint
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Placement of either above knee/around knee/below knee neoplene sleeve and non-wearing control
Interventions/Control_2
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
40 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult aged 20 years old or older but younger than 40 years old.
Key exclusion criteria 1) joint disorders
2) skin infection
3) musculoskeletal disorder
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoichi Nagatomi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address Seiryo-cho 2-1, Aoba-ku, 980-8575 Sendai, Japan
TEL 022-717-8586
Email nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoichi Nagatomi
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
Zip code
Address Seiryo-cho 2-1, Aoba-ku, 980-8575 Sendai, Japan
TEL 022-717-8586
Homepage URL
Email nagatomi@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Tohoku University
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
Address
Tel
Email

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
2018 Year 06 Month 18 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
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
2018 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 18 Day
Last follow-up date
2018 Year 10 Month 29 Day
Date of closure to data entry
2018 Year 10 Month 29 Day
Date trial data considered complete
2018 Year 10 Month 29 Day
Date analysis concluded
2018 Year 11 Month 09 Day

Other
Other related information

Management information
Registered date
2018 Year 06 Month 07 Day
Last modified on
2019 Year 01 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037519

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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