UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035690
Receipt number R000040654
Scientific Title Kinaesthetic movement reproduction following a prior bout of isokinetic eccentric exercise with or without a below-knee compression garment in healthy adults
Date of disclosure of the study information 2019/01/28
Last modified on 2021/02/09 12:17:53

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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 or person

Institute

Tohoku University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name