UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000047146
Receipt number R000053781
Scientific Title The modulation of spinal pathways at rest, standing, and during walking
Date of disclosure of the study information 2022/03/11
Last modified on 2022/03/11 03:44:08

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Basic information

Public title

The modulation of spinal pathways during walking

Acronym

The modulation of spinal pathways during walking

Scientific Title

The modulation of spinal pathways at rest, standing, and during walking

Scientific Title:Acronym

The modulation of spinal pathways at rest, standing, and during walking

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the modulation of spinal pathways at rest, standing, and during walking

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Electrophysiological assessment of spinal reciprocal inhibition and heteronymous pathways

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

50 years-old >=

Gender

Male and Female

Key inclusion criteria

Person who have received a sufficient explanation for participating in this study and have obtained written consent with sufficient understanding

Key exclusion criteria

History of orthopedic or neurological disorder

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Yoko
Middle name
Last name Takahashi

Organization

Juntendo University

Division name

Faculty of Health Science

Zip code

113-0033

Address

3-2-12, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Email

y.takahashi.jk@juntenco.ac.jp


Public contact

Name of contact person

1st name Yoko
Middle name
Last name Takahashi

Organization

Juntendo University

Division name

Faculty of Health Science

Zip code

113-0033

Address

3-2-12, Hongo, Bunkyo-ku, Tokyo

TEL

03-3813-3111

Homepage URL


Email

y.takahashi.jk@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo Univeristy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Research Ethics Committee, Faculty of Health Science

Address

3-2-12, Hongo, Bunkyo-ku, Tokyo

Tel

03-3813-3111

Email

y.tatakashi.jk@juntendo.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

21-012

Org. issuing International ID_1

Research Ethics Committee, Faculty of Health Science

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 03 Month 11 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

Enrolling by invitation

Date of protocol fixation

2021 Year 07 Month 30 Day

Date of IRB

2021 Year 12 Month 07 Day

Anticipated trial start date

2021 Year 12 Month 10 Day

Last follow-up date

2024 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Evaluation of spinal reciprocal inhibition and heteronymous pathways at rest, standing, and during walking
Pilot data for future investigation in patients with stroke


Management information

Registered date

2022 Year 03 Month 11 Day

Last modified on

2022 Year 03 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053781