UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000060254
Receipt number R000068919
Scientific Title An experimental study on the relationship between physical fatigue and stress assessed by gait parameters among nursing professionals using an in-shoe motion sensor (A-RROWG)
Date of disclosure of the study information 2026/01/05
Last modified on 2026/01/05 10:37:54

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Basic information

Public title

A Study Investigating the Relationship Between Nurses' Walking Patterns and Fatigue and Stress

Acronym

N/A

Scientific Title

An experimental study on the relationship between physical fatigue and stress assessed by gait parameters among nursing professionals using an in-shoe motion sensor (A-RROWG)

Scientific Title:Acronym

NGFS study

Region

Japan


Condition

Condition

Not applicable (healthy nursing professionals)

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the relationship between gait parameters obtained during walking and indicators of physical fatigue and stress before and after work among hospital nurses.

Basic objectives2

Others

Basic objectives -Others

To examine the association between gait parameters and indicators of physical fatigue and stress before and after work among nurses.

Trial characteristics_1

Others

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes in gait parameters (e.g., walking speed, step length, stance time) before and after work and their association with subjective fatigue and stress-related measures.

Key secondary outcomes

Changes in subjective fatigue scores

Changes in sleep-related questionnaire scores

Changes in lower-leg edema measurements


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

[For assessment purposes] Participants perform a 10-minute walking task before and after work (over 3 days; 6 sessions in total) to measure gait parameters. An in-shoe motion sensor (A-RROWG) is worn during walking, and questionnaires are administered. This task is not a therapeutic or performance-improving training intervention.

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Hospital nurses
Able to walk independently for at least 10 minutes
Provided written informed consent after understanding the study

Key exclusion criteria

Individuals with neurological or orthopedic conditions affecting gait
Individuals with severe cardiopulmonary disease
Individuals experiencing pain or poor physical condition at the time of measurement

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Emiko
Middle name
Last name Aoki

Organization

Kawasaki City College of Nursing

Division name

School of Nursing

Zip code

212-0054

Address

30-1, Ogura 4-chome, Saiwai Ward, Kawasaki City, Kanagawa Prefecture

TEL

044-587-3500

Email

aoki-e@kawasaki-cn.ac.jp


Public contact

Name of contact person

1st name Emiko
Middle name
Last name Aoki

Organization

Kawasaki City College of Nursing

Division name

School of Nursing

Zip code

212-0054

Address

30-1, Ogura 4-chome, Saiwai Ward, Kawasaki City, Kanagawa Prefecture

TEL

044-587-3500

Homepage URL


Email

aoki-e@kawasaki-cn.ac.jp


Sponsor or person

Institute

Kawasaki City College of Nursing

Institute

Department

Personal name



Funding Source

Organization

Kawasaki City College of Nursing

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

Kawasaki City University of Nursing Ethics Review Committee

Address

30-1, Ogura 4-chome, Saiwai Ward, Kawasaki City, Kanagawa Prefecture

Tel

044-587-3500

Email

40kangos@city.kawasaki.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

2026 Year 01 Month 05 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

Preinitiation

Date of protocol fixation

2026 Year 01 Month 05 Day

Date of IRB


Anticipated trial start date

2026 Year 01 Month 05 Day

Last follow-up date

2027 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2026 Year 01 Month 05 Day

Last modified on

2026 Year 01 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068919