UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037792
Receipt number R000042801
Scientific Title Establishing a new quantification method of lower limbs movement coordination and validating the relationship with symptoms of the diseases
Date of disclosure of the study information 2019/09/02
Last modified on 2023/04/02 14:46:11

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Basic information

Public title

Establishing a new quantification method of lower limbs movement coordination and validating the relationship with symptoms of the diseases

Acronym

Relationship lower limbs movement coordination and symptoms of the diseases

Scientific Title

Establishing a new quantification method of lower limbs movement coordination and validating the relationship with symptoms of the diseases

Scientific Title:Acronym

Relationship lower limbs movement coordination and symptoms of the diseases

Region

Japan


Condition

Condition

Lower extremity orthopedic diseases

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship lower limb movement coordination of the patients who have lower extremity orthopedic disease and symptoms of diseases

Basic objectives2

Others

Basic objectives -Others

To clarify the influence of the lower limb movement coordination on the changes of symptoms before and after the surgery in the lower extremity orthopedic diseases patients

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Kinematic variables of lower extremity
kinetic variables of lower extremity
Electromyographic signals of lower limb muscles
Symptoms of diseases from questionnaire

Key secondary outcomes



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

Prevention

Type of intervention

Other

Interventions/Control_1

Normal gait(10 trials)
Running(10 trials)
Squat(10 trials)
Landing(10 trials)
Ascend and descend stairs(10 trials)
Stepping(10 trials)

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

16 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Persons who can walk without being helped
2.Persons who write informed consent

Key exclusion criteria

1.Persons who had a history of orthopedic operation in spine or lower limbs, or given either a diagnosis of as having a central nervous system disease, a mental disease and dementia.
2.Persons can not walk more than 10m.
3.Persons who deemed inappropriate for this study by doctor.
4.Persons relating to researchers as the student and a teacher, and attending the lecture of the study person in charge.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Nobuo
Middle name
Last name Adachi

Organization

Hiroshima University Hospital

Division name

Department of Orthopedic Surgery

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima

TEL

082-527-5232

Email

nadachi@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Minoru
Middle name
Last name Toriyama

Organization

Hiroshima University

Division name

Graduate School of Biomedical and Health Sciences

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima

TEL

082-527-5232

Homepage URL


Email

d181008@hiroshima-u.ac.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor

Saiseikai Kure Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hiroshima University Clinical study ethic screening committee

Address

1-2-3 Kasumi, Minami-ku, Hiroshima, Hiroshima

Tel

082-257-1551

Email

kasumi-kenkyu@office.hiroshima-u.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 09 Month 02 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

2019 Year 08 Month 23 Day

Date of IRB

2019 Year 09 Month 02 Day

Anticipated trial start date

2019 Year 09 Month 03 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

2019 Year 08 Month 24 Day

Last modified on

2023 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042801


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name