UMIN-CTR Clinical Trial

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	2018 Year 06 Month 18 Day
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	2021 Year 02 Month 09 Day

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