UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043801
Receipt number R000049361
Scientific Title Muscle synergy analysis during arm elevation using the electromyography and the three-dimensional analysis
Date of disclosure of the study information 2021/03/31
Last modified on 2023/10/02 12:46:52

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Basic information

Public title

Muscle synergy analysis during arm elevation using the electromyography and the three-dimensional analysis

Acronym

Muscle synergy analysis during arm elevation

Scientific Title

Muscle synergy analysis during arm elevation using the electromyography and the three-dimensional analysis

Scientific Title:Acronym

Muscle synergy analysis during arm elevation

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Orthopedics Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To conduct muscle synergy analysis using electromyography and three-dimensional motion analysis equipment in healthy adults to clarify the pattern (synergy) of elevation movements in the normal shoulder joint.

Basic objectives2

Others

Basic objectives -Others

Muscle synergy of arm elevation in the normal shoulder joint

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To find the synergy of arm elevation in the normal shoulder joint.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

expanded access

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

Other

Interventions/Control_1

Study period: 1 day
Post-obserStudy period: 1 day
Post-observation period: 1 week
1) Insertion of wire electrodes: Under local anesthesia, wire electrodes are inserted into the supraspinatus and subscapularis muscles on the right-side using echography.
2) Application of surface electrodes: Surface electrodes are applied to the muscle bellies of the anterior, middle, and posterior deltoid muscle and the upper, middle, and lower trapezius muscle, and infraspinatus muscle, and serratus anterior muscle.
3) Attachment of markers for three-dimensional motion analysis: Markers for three-dimensional motion analysis are attached to the spinous process of the cervical spine, the spinous process of the thoracic spine, the medial margin of the scapular spine, the inferior angle of the scapula, the posterior lateral margin of the acromion, the coracoid process, the median, lateral and medial epicondyles of the humerus, and the stalk-like processes of the radius and ulna of the forearm bone.
4) Perform shoulder raising motions in three directions (anterior raising, scapular plane raising, lateral raising), and simultaneously perform electromyography and three-dimensional motion analysis during the raising motion.

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

Healthy adults 20 years of age or older with no shoulder symptoms

Key exclusion criteria

(1) Patients with a history of or complications from orthopedic, neurological, or psychiatric disorders with symptoms of motor or sensorimotor dysfunction affecting upper limb movement.
2) Those with cognitive impairment.
3) Those who are allergic to local anesthetics, alcohol, or metals.
3) Those who are allergic to local anesthetics, alcohol, or metals. 4) Those who are taking anticoagulants or antiplatelet agents.
(5) Those who have an interest in the researcher or the principal investigator (including those who may receive lectures from the researcher)
(vi) Others who are judged by the principal investigator or sub-investigator to be inappropriate to conduct this research.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Toru
Middle name
Last name Sunagawa

Organization

Hiroshima University School of Medicine

Division name

Analysis and Control of Upper Extremity Function

Zip code

734-8551

Address

1-2-3 Kasumi Minami-ku Hiroshima

TEL

082-257-5232

Email

torusuna@hiroshima-u.ac.jp


Public contact

Name of contact person

1st name Yohei
Middle name
Last name Harada

Organization

Hiroshima University

Division name

Department of Orthopaedic Surgery, GraduateSchool of Biomedical and Health Sciences

Zip code

734-8551

Address

1-2-3 Kasumi Minami-ku Hiroshima

TEL

082-257-5232

Homepage URL


Email

hyarada@yahoo.co.jp


Sponsor or person

Institute

Hiroshima University

Institute

Department

Personal name



Funding Source

Organization

Analysis and Control of Upper Extremity Function

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 for Clinical Research of Hiroshima University

Address

1-2-3 Kasumi Minami-ku Hiroshima

Tel

082-257-155

Email

iryo-seisaku@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

2021 Year 03 Month 31 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

No longer recruiting

Date of protocol fixation

2021 Year 03 Month 31 Day

Date of IRB

2021 Year 03 Month 31 Day

Anticipated trial start date

2021 Year 03 Month 31 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To analyze the muscle activity (muscle synergy) of the periarticular muscles of the shoulder joint during shoulder elevation using three-dimensional motion analysis and electromyography in healthy adults.
(1) Patients with a history of or complications from orthopedic, neurological, or psychiatric disorders with symptoms of motor or sensorimotor dysfunction affecting upper limb movement.


Management information

Registered date

2021 Year 03 Month 31 Day

Last modified on

2023 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049361


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name