UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015287
Receipt number R000017777
Scientific Title Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke.
Date of disclosure of the study information 2014/10/01
Last modified on 2017/04/25 08:53:55

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Basic information

Public title

Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke.

Acronym

Development of the system of the motion analysis of the ADL in patients with hemiparetic stroke.

Scientific Title

Development of the system of the clinical motion analysis of the ADL activity related upper extremity in patients with hemiparetic stroke.

Scientific Title:Acronym

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

1st name
Middle name
Last name Meigen Liu

Organization

Keio University School of Medicine
,Japan

Division name

Department of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi,Shinjyuku-ku,Tokyo,

TEL

03-5363-3833

Email

meigenliukeio@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Atsuko Nishimoto

Organization

Graduate School of Medicine,Keio University

Division name

Department of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi,Shinjyuku-ku,Tokyo,

TEL

03-5363-3833

Homepage URL


Email

sakurasaku710eena@gmail.com


Sponsor or person

Institute

Keio University School of Medicine,
Japan

Institute

Department

Personal name



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)



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

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


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

Completed

Date of protocol fixation

2014 Year 05 Month 26 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017777


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name