UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke.
Title of the study (Brief title)	Development of the system of the motion analysis of the ADL in patients with hemiparetic stroke.
Region	Japan

Condition
Condition	STROKE
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	1.To build a motion analysis system to evaluate the ADL activity related upper extremity,folding a towel, carrying a cup to the mouth and opening a plastic bottle,objectively. 2. To measure the ADL activity related upper extremity on the same condition using the motion analysis system we built twice for less than one week and examine the reliability of the evaluation index.
Basic objectives2	Others
Basic objectives -Others	Motion analysis
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1.Basic information in patients with stroke ,age and sex 2.The parameters related in stroke Type,lesion,part,onset after stroke,complication 3.The parameters related in dysfunction,desease severity of motor paralysis, sensory dysfunction and contracture,higher brain disfunction,degree of ADL independence,utility of upper extrimity. 4.Motion analysis evaluation index of ADL movement,Range of motion,time of motion,velocity,Muscle activity,length of motion.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	We measure the ADL activity related upper extremity using the motion analysis system we built to about 10 healthy subjects.
Interventions/Control_2	We measure the second ADL activity related upper extremity using the motion analysis system we built to the same (interventions 1) 10 healthy subjects for less than one week.
Interventions/Control_3	After measuring to the healthy subjects,we measure the ADL activity related upper extremity using the motion analysis system to 10 hemiparetic subjects under the same conditions with the healthy group.
Interventions/Control_4	We measure the second ADL activity related upper extremity using the motion analysis system we built to the same (interventions 3) 10 hemiparetic subjects for less than one week.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Over 20 years old 2.Hemiparesis due to unilateral hemispheric lesion 3.With motor dysfunction of upper extremity 4.150days and over from stroke onset 5.Can keep sitting by oneself 6.Without higher cortical dysfunction 7.Range of motion of the affected upper extremity:shoulder flexion90,elbow extention-40,finger extention0 8.Without severe pain of the affected upper extremity 9.Without severe deep sensory disturbance
Key exclusion criteria	/The enforcement of the clinical evaluation is difficult /Condition unstable medically /Contraindications to upper extremity exercise 1.Severe heart failure 2.Poorly controlled hyper tension 3.Acute systemic disease or fever 4.Acute pulmonary embolism 5.Severe hepatic dysfunction and renal dysfunction 6.Orthopedic diseases which may disturb upper extremity functions 7.With severe cognitive and mental dis orders 8.With metabolic disorders such as acute thyroiditis
Target sample size	20

Research contact person
Name of lead principal investigator	Meigen Liu
Organization	Keio University School of Medicine ,Japan
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi,Shinjyuku-ku,Tokyo,
TEL	03-5363-3833
Email	meigenliukeio@mac.com

Public contact
Name of contact person	Atsuko Nishimoto
Organization	Graduate School of Medicine,Keio University
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi,Shinjyuku-ku,Tokyo,
TEL	03-5363-3833
Homepage URL
Email	sakurasaku710eena@gmail.com

Sponsor
Institute	Keio University School of Medicine, Japan
Institute
Department

Funding Source
Organization	Strategic Research Program for Brain Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	慶應義塾大学病院（東京都）　KEIO UNIVERSITY HOSPITAL.TOKYO,JAPAN

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 26 Day
Anticipated trial start date	2014 Year 10 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

Management information
Registered date	2014 Year 09 Month 30 Day
Last modified on	2017 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017777