UMIN-CTR Clinical Trial

Basic information
Public title	Kinaesthetic movement reproduction following a prior bout of isokinetic eccentric exercise with or without a below-knee compression garment in healthy adults
Acronym	Below knee compression garment and joint position sensing after fatiguing exercise
Scientific Title	Kinaesthetic movement reproduction following a prior bout of isokinetic eccentric exercise with or without a below-knee compression garment in healthy adults
Scientific Title:Acronym	Below knee compression garment and joint position sensing after fatiguing exercise
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The primary objective of this study is to investigate the effects of a below-knee CG on the fatiguing mechanism, induced by isokinetic training, on knee proprioception in healthy young adults. Specifically, we aim to determine how kinaesthetic movement reproduction is affected following a prior bout of isokinetic eccentric exercise on a dynamometer with or without a below-knee CG.
Basic objectives2	Others
Basic objectives -Others	Furthermore, we aim to investigate if changes in proprioception would still exit 24 hours and one week after the intervention.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Kinaesthetic movement reproduction
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	below knee compression garment/fatiguing knee isokinetic exercise
Interventions/Control_2	no garment/fatiguing knee isokinetic exercise
Interventions/Control_3	below knee compression garment/no exercise
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	1) 20 year or older, younger than 40. 2) Right side dominant (both upper and lower limb)
Key exclusion criteria	1) current knee joing disorder 2) current skin infection 3) current motor dysfunction 4) past and current renal dysfunction
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
TEL	+81-22-717-8586
Email	nagatomi@med.tohoku.ac.jp

Public contact
Name of contact person	1st name Ryoichi Middle name Last name Nagatomi
Organization	Tohoku University
Division name	Graduate School of Biomedical Engineering
Zip code	980-8575
Address	Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
TEL	+81-22-717-8586
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	Ethics Committee Tohoku University Graduate School of Medicine
Address	Seiryo-cho 2-1, Aoba-ku, Sendai 980-8575
Tel	022-717-8007
Email	med-kenkyo@grp.tohoku.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

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 10 Month 06 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 01 Month 31 Day
Date of IRB	2019 Year 01 Month 28 Day
Anticipated trial start date	2019 Year 01 Month 31 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 01 Month 28 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=R000040654