UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014053
Receipt number R000016363
Scientific Title Development of a clinical reaching assessment scale for patients with hemiparetic stroke
Date of disclosure of the study information 2014/05/23
Last modified on 2017/04/27 21:18:18

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Basic information

Public title

Development of a clinical reaching assessment scale for patients with hemiparetic stroke

Acronym

Development of a clinical reaching assessment scale for patients with hemiparetic stroke

Scientific Title

Development of a clinical reaching assessment scale for patients with hemiparetic stroke

Scientific Title:Acronym

Development of a clinical reaching assessment scale for patients with hemiparetic stroke

Region

Japan


Condition

Condition

patients with hemiparetic stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop a practical and objective reaching assessment scale, and to verify its reliability, validity, and responsiveness.

Basic objectives2

Others

Basic objectives -Others

Psychometric properties

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Inter-rater reliability
Intra-rater reliability
Concurrent validity with the severity of upper-extremity motor paralysis, spasticity and so on.
responsiveness

Key secondary outcomes



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


Not applicable

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) 150 days and over from stroke onset
5) Can keep sitting by oneself
6) Without higher cortical dysfunctions that hinder clinical assessment
7) Range of motion of the affected upper extremity : shoulder flexion over 90 degrees,elbow extension over -40 degrees,finger extension over 0 degree
8) Without severe pain of the affected upper extremity
9) Without severe deep sensory disturbance
10) Videos that recorded reaching are available

Key exclusion criteria

Contraindications to upper extremity exercise (details as described below)
1)Severe heart diseases such as unstable angina, recent onset myocardial infarction, decompensated congestive heart failure, acute core pulmonare, poorly controlled arrythmia, severe aortic valvular disease, active myocarditis, pericarditis and so on.
2)Poorly controlled 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

03-5363-3833

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

Project for Research Initiatives and Development of National problem correspondence

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 05 Month 23 Day


Related information

URL releasing protocol

http://www.keio-reha.com/rinnsyoukenkyu/index.html

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 02 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

classification of sex, age, disease type of stroke, lesions caused by stroke, medical treatment, disease duration, motor dysfunction, sensory dysfunction, spasticity, range of motion, higher brain dysfunction and so on


Management information

Registered date

2014 Year 05 Month 23 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=R000016363


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name