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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027306
Receipt No. R000031261
Scientific Title The reliability and validity study about upper limb function using peg including pressure and position sensor (Intelligent Peg)
Date of disclosure of the study information 2017/05/11
Last modified on 2019/03/26

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Basic information
Public title The reliability and validity study about upper limb function using peg including pressure and position sensor (Intelligent Peg)
Acronym The reliability and validity study about upper limb function using Intelligent Peg
Scientific Title The reliability and validity study about upper limb function using peg including pressure and position sensor (Intelligent Peg)
Scientific Title:Acronym The reliability and validity study about upper limb function using Intelligent Peg
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this study is investigation about the feasibility, reliability and validity of the assessment system of upper limb function
using peg including pressure and position sensor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes movement time of peg
time required for evaluation (preparation, measurement)
QUEST2.0
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 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 The participants perform peg movement using Intelligent Peg and are evaluated motor function of paretic upper limb (prasp of the peg, movement time fo the peg, and trace of the peg). They participated in the second session at intervals of 48 hours to evaluate the reliability.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Stroke patients with hemiparesis;
no cognitive deficits;
less than four scores of SIAS knee-mouth test;
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
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 Michiyuki Kawakami
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 michiyukikawakami0212@yahoo.co.jp

Sponsor
Institute Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 11 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
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 05 Month 11 Day
Anticipated trial start date
2017 Year 05 Month 12 Day
Last follow-up date
2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 11 Day
Last modified on
2019 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031261

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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