UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000050400
Receipt number R000057389
Scientific Title Kinematic analysis of scapulothoracic joint and glenohumeral joint in walking
Date of disclosure of the study information 2023/02/21
Last modified on 2023/02/22 13:55:13

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Basic information

Public title

Kinematic analysis of scapulothoracic joint and glenohumeral joint in walking

Acronym

Kinematic analysis of scapulothoracic joint and glenohumeral joint in walking

Scientific Title

Kinematic analysis of scapulothoracic joint and glenohumeral joint in walking

Scientific Title:Acronym

Kinematic analysis of scapulothoracic joint and glenohumeral joint in walking

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The scapula related to the trunk and the upper limb motion related to the scapula during walking are measured and analyzed using a three-dimensional motion analysis. From the obtained results, the relationship between scapula motion and upper limb motion during walking will be clarified.

Basic objectives2

Others

Basic objectives -Others

Non-invasively perform Objective 1.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Scapular motion to the trunk coordinate system: raising, lowering, internal rotation, external rotation, anterior tilt, posterior tilt
and upper arm movements relative to the scapula coordinate system: flexion, extension, adduction, abduction, internal rotation, and external rotation

Key secondary outcomes

Scapular motion to the upper arm movements relative to the scapula coordinate system: flexion, extension, adduction, abduction, internal rotation, and external rotation


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

Behavior,custom

Interventions/Control_1

Walking motion in three-speed conditions with a comfortable walking speed of 110steps/min and +/-10% walking speed. Walking movements that the subject performs daily to move around in order to measure natural gait movement behavior.

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

18 years-old <=

Age-upper limit

25 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy university students
Between 18 and 25 years of age with the ability to self-determine
Gender-neutral

Key exclusion criteria

Minors
Persons with limitations in walking or movement
Persons with pain (back pain, lower limb/foot pain) or lightheadedness (dizziness or medication) that affects walking activities.
Persons who have had hip dislocation or scoliosis noted during medical examinations or other medical examinations.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yutaka
Middle name
Last name Sawada

Organization

Saitama Medical University

Division name

School of Physical Therapy, Faculty of Health and Medical Care

Zip code

350-0496

Address

981 Kawakado Moroyama-Machi Irumagun Saitama Japan

TEL

049-295-1001

Email

ysawada@saitama-med.ac.jp


Public contact

Name of contact person

1st name Yutaka
Middle name
Last name Sawada

Organization

Saitama Medical University

Division name

School of Physical Therapy, Faculty of Health and Medical Care

Zip code

350-0496

Address

981 Kawakado Moroyama-Machi Irumagun Saitama Japan

TEL

049-295-1001

Homepage URL


Email

ysawada@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University
Faculty of Health and Medical Care
School of Physical Therapy

Yutaka Sawada

Institute

Department

Personal name



Funding Source

Organization

Saitama Medical 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

Ethical Committee of Saitama Medical University

Address

38 Morohongo Moroyama-Machi Iruma-gun Saitama Japan

Tel

049-276-2143

Email

rinri@saitama-med.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

2023 Year 02 Month 21 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

2023 Year 02 Month 21 Day

Date of IRB


Anticipated trial start date

2023 Year 02 Month 21 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Subject recruitment phase. Before the start of observation.


Management information

Registered date

2023 Year 02 Month 21 Day

Last modified on

2023 Year 02 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057389


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name