UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032562
Receipt number R000037138
Scientific Title Motion analysis for standardization of therapeutic sit-to-stand assistance for acute stroke patients
Date of disclosure of the study information 2018/05/12
Last modified on 2018/05/12 13:33:15

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Basic information

Public title

Motion analysis for standardization of therapeutic sit-to-stand assistance for acute stroke patients

Acronym

Motion analysis for standardization of therapeutic sit-to-stand assistance for acute stroke patients

Scientific Title

Motion analysis for standardization of therapeutic sit-to-stand assistance for acute stroke patients

Scientific Title:Acronym

Motion analysis for standardization of therapeutic sit-to-stand assistance for acute stroke patients

Region

Japan


Condition

Condition

stroke

Classification by specialty

Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the relationship between the muscle activity pattern and the ability to output the power at each joint in sit-to-stand task in an acute stroke patient.

Basic objectives2

Others

Basic objectives -Others

We investigate the relationship between the muscle activity pattern and the ability to output the power at each joint in sit-to-stand task in an acute stroke patient. This makes it possible to clarify which joint force the motor paralysis exerts in the sit-to-stand task (or it is weaker compared to a healthy subject), so it can be the basic data for standardization of the sit-to-stand motion assistance.

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Surface electromyogram data at 1 week to 2 weeks after onset

Key secondary outcomes

Joint angle data, Fugl-mayer-assesment score at 1 week to 2 weeks after onset


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) first ischemic/hemorrhagic stroke; (2) unilateral weakness; (3) <2 weeks post-stroke.

Key exclusion criteria

(1) other neurological or orthopedic conditions; (2) major cognitive deficits as assessed by standard tests; (3) sitting balance or trunk stability deficits

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Hanawa

Organization

Graduate School of Saitama Prefectural University

Division name

Graduate Course of Health and Social Services

Zip code


Address

820 San-Nomiya, Koshigaya-shi, Saitama, 343-8540, Japan

TEL

048-971-0500

Email

1991005n@spu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Hanawa

Organization

Graduate School of Saitama Prefectural University

Division name

Graduate Course of Health and Social Services

Zip code


Address

820 San-Nomiya, Koshigaya-shi, Saitama, 343-8540, Japan

TEL

048-971-0500

Homepage URL


Email

1991005n@spu.ac.jp


Sponsor or person

Institute

Graduate School of Saitama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

東埼玉総合病院(埼玉県)


Other administrative information

Date of disclosure of the study information

2018 Year 05 Month 12 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

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

[Overview]
The effectiveness of muscle synergy analysis as a means to quantify motor paralysis has recently been established and adopted in this study. Also, in motion analysis, it is important not only to follow joint motion but also to what extent the ability of each joint contributes to the overall force output. For this reason, we calculate complex inverse dynamics calculation from joint angle measurement. Furthermore, large devices such as three-dimensional motion analysis devices have poor practicality in the clinical setting. Thus we collect many patient data from small devices such as wireless surface electromyogrammeters and accelerometers.
[Target audience]
Acute stroke patients (within 2 weeks after onset)
[Used equipment]
Wireless surface electromyography (Oisaka Electronics Co., Ltd.)
Small accelerometer (Oisaka Electronics Co., Ltd.)
Compact force sensor (Leptrino Co., Ltd.)
force sensor (Unimec Co., Ltd.)
[Experimental issue]
Subjects perform sit-to-stand task from the wheelchair with a cue. For the sit-to-stand, subjects use a cane to assist the balance.
[Analytical method]
We extract the data during the sit-to-stand task of measured joint angle, floor reaction force, electromyogram data of whole body and use it for subsequent analysis. From the joint angle, the force exerted by each joint is calculated from the inverse dynamics calculation. Extract abnormal muscle synergy by applying nonnegative matrix factorization, which is one of pattern recognition methods, to EMG data.
[Statistical analysis]
Apply hierarchical cluster analysis to all subject data with the ratio of each joint force to the rotational force around the whole body center of gravity as an index. Regarding the classification by hierarchical cluster analysis, regression analysis is carried out to how much quantified motor paralysis contributes.


Management information

Registered date

2018 Year 05 Month 12 Day

Last modified on

2018 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037138


Research Plan
Registered date File name

Research case data specifications
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Research case data
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