UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000023314
Receipt number	R000026863
Scientific Title	Safty examination of using the measurement machine of wrist spasticity
Date of disclosure of the study information	2016/07/25
Last modified on	2018/02/08 18:23:22

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Basic information

Public title

Safty examination of using the measurement machine of wrist spasticity

Acronym

Safty examination of measurement of spasticity

Scientific Title

Safty examination of using the measurement machine of wrist spasticity

Scientific Title:Acronym

Safty examination of measurement of spasticity

Region

Japan

Condition

central nervous disiease

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To study the safety of the measurement machine of wrist spasticity

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

subjective symptoms (pain, swelling)

Key secondary outcomes

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

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

measurement by the measurement machine of wrist spasticity

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

15 years-old <=

Age-upper limit

90 years-old >=

Gender

Male and Female

Key inclusion criteria

the patients who have paretic uper limbs (Modified Ashworth Scale more than 1)

Key exclusion criteria

unstable condition.
the patients who have painful upper limbs.
passive range of motion of wrist was less than 90 degree.
bone YAM was less than 70%.
severe aphasia.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Seiji Etoh

Organization

Guraduate school of Kagoshima University

Division name

Department of physical medicine and rehabilitation

Zip code

Address

Takachiho 3930-7, Makizono-cho, Kirishima-City, Kagoshima

TEL

0995782538

Email

etohs@m2.kufm.kagoshima-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Seiji Etoh

Organization

Guraduate school of Kagoshima University

Division name

Department of physical medicine and rehabilitation

Zip code

Address

Takachiho 3930-7, Makizono-cho, Kirishima-City, Kagoshima

TEL

0995782538

Homepage URL

Email

etohs@m2.kufm.kagoshima-u.ac.jp

Sponsor or person

Institute

Kagoshima University

Institute

Department

Personal name

Funding Source

Organization

self funding

Organization

Division

Category of Funding Organization

Self funding

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 25 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

2016 Year 04 Month 12 Day

Date of IRB

Anticipated trial start date

2016 Year 07 Month 25 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

2016 Year 07 Month 24 Day

Last modified on

2018 Year 02 Month 08 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026863

Research Plan
Registered date	File name
2016/07/29	手関節痙縮測定装置研究計画書.doc

Research case data specifications
Registered date	File name
2017/08/04	手関節痙縮測定装置研究症例データ仕様書.xlsx

Research case data
Registered date	File name
2017/09/19	手関節痙縮測定装置研究症例データ.xlsx

Single case data URL

Value
https://center6.umin.ac.jp/ice/26863