UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034380
Receipt number R000039196
Scientific Title Electromyogram analysis of muscle synergy for stroke patients with hemiplegia
Date of disclosure of the study information 2018/10/05
Last modified on 2023/04/08 13:41:09

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Basic information

Public title

Electromyogram analysis of muscle synergy for stroke patients with hemiplegia

Acronym

Electromyogram analysis of muscle synergy for stroke patients

Scientific Title

Electromyogram analysis of muscle synergy for stroke patients with hemiplegia

Scientific Title:Acronym

Electromyogram analysis of muscle synergy for stroke patients

Region

Japan


Condition

Condition

Stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to analyze the muscle synergy which is motion signal of central nerve system from stroke patient's upper extremity by surface electromyogram, and to observe the time-dependent change of same patient and the difference due to the severity.

Basic objectives2

Others

Basic objectives -Others

Evaluation

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle synergy

Key secondary outcomes

Surface electromyogram
Motor items of Stroke Impairment Assessment Set
Brunnstrom stage


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

Device,equipment

Interventions/Control_1

The subject of this study is stroke patients in rehabilitation hospital. Surface electromyogram is measured while the subject moves by affixed to 6 upper extremity muscles of both (sound and affected) side. Every 20 minutes measurement per 2 weeks, total 4 times.

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

General condition is stable
Sitting position retention possible
Informed-consent has been obtained

Key exclusion criteria

High-blood pressure, systolic blood pressure over 180 mmHg or diastolic blood pressure over 120 mmHg or resting heart rate over 120/min
Restricted by movement due to heart function or respiratory function disorder
hearing or visual impairment
Dementia or severe higher brain dysfunction

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Izumi
Middle name
Last name Kondo

Organization

National Center for Geriatrics and Gerontology

Division name

Rehabilitation Center

Zip code

474-8511

Address

7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan

TEL

0562-46-2311

Email

ik7710@ncgg.go.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Ozaki

Organization

National Center for Geriatrics and Gerontology

Division name

Rehabilitation Center

Zip code

474-8511

Address

7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan

TEL

0562-46-2311

Homepage URL


Email

ozk-kety@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



Funding Source

Organization

TOYOTA motor corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Center for Geriatrics and Gerontology

Address

7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan

Tel

0562-46-2311

Email

sumiyami@ncgg.go.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

国立長寿医療研究センター


Other administrative information

Date of disclosure of the study information

2018 Year 10 Month 05 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

32

Results

Thirty-two patients (20 males, 12 females, mean age 72 years) in the recovery to maintenance phase of stroke underwent muscle synaptic measurement.
No measurement-related adverse events were observed.
Self-support with the nonparalyzed upper limb significantly increased the amplitude of EMG on the paralyzed side.

Results date posted

2023 Year 04 Month 08 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients with hemiplegia due to stroke during hospitalization or after discharge from the recovery rehabilitation ward

Participant flow

Informed consent was obtained in writing after informed consent was given regarding the advantages and disadvantages of participation in the study.

Adverse events

No adverse events occurred.

Outcome measures

SIAS. BRS. myoelectric activity of upper limb muscles.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 04 Month 01 Day

Date of IRB

2013 Year 04 Month 23 Day

Anticipated trial start date

2014 Year 04 Month 01 Day

Last follow-up date

2021 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

2018 Year 10 Month 04 Day

Last modified on

2023 Year 04 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039196


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name