UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013100
Receipt number R000015268
Scientific Title Evaluation of reaching in patients with hemiparetic stroke: construction of a clinical motion analysis system
Date of disclosure of the study information 2014/02/07
Last modified on 2017/04/27 21:17:40

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Basic information

Public title

Evaluation of reaching in patients with hemiparetic stroke: construction of a clinical motion analysis system

Acronym

Motion analysis of reaching in patients with hemiparetic stroke

Scientific Title

Evaluation of reaching in patients with hemiparetic stroke: construction of a clinical motion analysis system

Scientific Title:Acronym

Motion analysis of reaching in patients with hemiparetic stroke

Region

Japan


Condition

Condition

Patients with upper limb impairments and healthy persons

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1) To develop a practical and clinically relevant kinematic motion analysis system, and to verify its reliability, validity, responsiveness and practicability
2) To investigate reaching impairment in patients with stroke with the system we will develop, and to evaluate its relation with clinical factors

Basic objectives2

Others

Basic objectives -Others

Motion analysis

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Reaching movement parameters in healthy persons and patients with stroke using motion analysis system
(time needed, acceleration, velocity, displacement, joint angle, muscle activity and so on)

Key secondary outcomes

Subjective evaluation of the burden imposed by wearing the system with visual analog scale(VAS) or free comments


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Evaluation of reaching with a motion analysis system

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients
1.Over 20 years old
2.Hemiparesis due to unilateral hemispheric lesion
3.With motor dysfunction of upper extremity
4.30 days and over from stroke onset
5.Can keep sitting by oneself
6.Without higher cortical dysfunctions
7.Range of motion of the affected upper extremity; shoulder flexion more than 90 degrees ,elbow extension more than -40 degrees ,finger extension more than 0 degree
8.Without severe pain of the affected upper extremity
9.Without severe deep sensory disturbance
10.Agreed to participate in the study
healthy persons:
1.Without past histories of musculoskeletal system (the arms) and neurologic diseases
2.Agreed to participate in the study

Key exclusion criteria

1)A pacemaker implanted
2)Contraindications to upper extremity exercise

1.Severe heart failure
2.Poorly controled hypertension
3.Acute systemic disease or fever
4.Acute pulmonary embolism, cor pulmonale, severe pulmonary hypertension
5.Severe hepatic dysfunction and renal dysfunction
6.Orthopedic diseases which may disturb upper extremity functions
7.With severe cognitive and mental disorders
8.With metabolic disorders such as acute thyroiditis

Target sample size

50


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, Japan

TEL

0353633833

Email

meigenliukeio@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Atsuko Horie

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan

TEL

03-5363-3833

Homepage URL


Email

atsukohorie7@gmail.com


Sponsor or person

Institute

Keio University School of Medicine, Japan

Institute

Department

Personal name



Funding Source

Organization

National model research and development promotion business for problem

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 KEIO UNIVSRSITY HOSPITAL


Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 07 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 01 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 07 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 02 Month 07 Day

Last modified on

2017 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015268


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name