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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032562
Receipt No. 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

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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
Institute Graduate School of Saitama Prefectural University
Institute
Department

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
URL(English) https://upload.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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