UMIN-CTR Clinical Trial

Public title

Investigation of the influence of walker on walking posture and walking behavior (muscle / nervous system)

Acronym

Investigation of the influence of walker on walking posture and walking behavior (muscle / nervous system)

Scientific Title

Investigation of the influence of walker on walking posture and walking behavior (muscle / nervous system)

Scientific Title:Acronym

Investigation of the influence of walker on walking posture and walking behavior (muscle / nervous system)

Region

Japan

Condition

Healthy person

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In this study, it is clarified what kind of influence each has on muscular system, nervous system, posture using three kinds of walkers (walker with four wheels, fixed walker, alternating walker) .

Basic objectives2

Others

Basic objectives -Others

Based on this research result in the future, we will clarify what sort of obstructed and what can be maintained by which walker by using the walker. In addition to medical professionals specialized in rehabilitation, the nurses who are closest to the patient also capture the features of the patient's motor function and the walker, so that the appropriate walker can be selected to encourage patient independence .

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Heart rate, autonomic nervous system (LF HF value), walking speed, brain wave (beta faction)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Measure the muscle activity at the time of using the walker with the surface electromyogram. The activity of the brain is measured with a surface electroencephalograph. The posture is measured with a surface electromyogram and a three-dimensional motion analyzer. The walker with a four-wheel caster is "walker A", the fixed walker is "walker B", and the alternating walker is "walker C", and walks in total of 12 patterns. Assign numbers 1 to 4 to 12 patterns and perform measurement in the order of the numbers appearing using the random number table. The measurement shall be a flat straight line of 10 m so that there is time to keep the walking speed constant, the operating speed is not specified taking into consideration the difference in physical strength of the research subject. The angle of the elbow is 90 degrees when the walker A is supported by the forearm. The walker B and the walker C adjust the angle of the elbow to 30 degrees when grasping the walker. In the three-dimensional motion analysis, the marker is attached to the hip joint, the knee joint, the ankle joint, the fifth metatarsal head, and the shoulder peak. The electromyogram is measured using a wireless biometric device. Measurement muscles of electromyogram are spinal column erector muscle mediastinalis muscle gastrocnemius muscle lateral right rectus femoris muscle. The surface electroencephalograph is measured using a wireless biometric device.Using an electroencephalograph, measure and evaluate the degree of concentration and relaxation to the task. The brain wave measurement site shall be the 10/20 method according to the international standard electrode placement method. Measure heart rate and respiratory rate as a method to evaluate the burden on the body. Measurements are made using a wireless biometric device. Electrocardiogram is measured at the left fourth intercostal clavicular middle line with 1 point, respiratory rate is measured by winding the measurement belt around the dove tail.

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

Age-lower limit

21

years-old

<=

Age-upper limit

29

years-old

>=

Gender

Male and Female

Key inclusion criteria

For those who do not have orthopedic surgeons / neurological problems and do not have a decline in motor function so as not to exhibit gait style features due to disease at walking.

Key exclusion criteria

Those who have had a history of orthopedic diseases or central nervous disorders or those who do not stand independently with ADL can exclude because there is a possibility that a difference in walking style of healthy subjects appears.
Because you use alcohol for disinfection, exclude those who are allergic to alcohol.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Sayuri Sakai

Organization

Niigata University

Division name

Graduate School of Health Sciences

Zip code

Address

Niigata-shi Niigata-shi Chuo-ku, Asahi-choamachi 746 second town

TEL

025-227-0941

Email

sakai@clg.niigata-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Sayuri Sakai

Organization

Niigata University

Division name

Graduate School of Health Sciences

Zip code

Address

Niigata-shi Niigata-shi Chuo-ku, Asahi-choamachi 746 second town

TEL

025-227-0941

Homepage URL

Email

sakai@clg.niigata-u.ac.jp

Institute

Niigata University

Institute

Department

Personal name

Organization

Niigata University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2018

Year

10

Month

20

Day

Date of IRB

2018

Year

10

Month

19

Day

Anticipated trial start date

2018

Year

10

Month

20

Day

Last follow-up date

2018

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

11

Month

27

Day

Last modified on

2022

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039937