UMIN-CTR Clinical Trial

Basic information
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
Condition	Healthy person
Classification by specialty	Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
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

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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	Niigata 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
Address
Tel
Email

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	2018 Year 11 Month 27 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	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
Other related information

Management information
Registered date	2018 Year 11 Month 27 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039937