UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Motion analysis for standardization of therapeutic sit-to-stand assistance for acute stroke patients
Title of the study (Brief title)	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	Hiroki Hanawa
Organization	Graduate School of Saitama Prefectural University
Division name	Graduate Course of Health and Social Services
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	Hiroki Hanawa
Organization	Graduate School of Saitama Prefectural University
Division name	Graduate Course of Health and Social Services
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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