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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027130
Receipt No. R000031086
Scientific Title Development of new upper limb function test method using three-dimensional motion analysis system
Date of disclosure of the study information 2017/04/25
Last modified on 2017/04/25

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Basic information
Public title Development of new upper limb function test method using three-dimensional motion analysis system
Acronym Development of new upper limb function test method using three-dimensional motion analysis system
Scientific Title Development of new upper limb function test method using three-dimensional motion analysis system
Scientific Title:Acronym Development of new upper limb function test method using three-dimensional motion analysis system
Region
Japan

Condition
Condition Healthy subjects,Upper limb dysfunction
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To establish indices to evaluate upper limb functions which are closely related the frequent movement patterns in daily life using the three-dimensional motion analysis system.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Displacement, speed and acceleration of markers placed on upper limb joints and trunk.
Key secondary outcomes Stroke Impairment Assessment Set (SIAS),Fugl-Meyer Assessment Scale (FMA),Functional Independence Measure (FIM)

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
Maneuver
Interventions/Control_1 To instruct the participants to perform the upper limb movement task and track the movements of markers placed on the upper limb and finger joints.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) healthy subjects
Persons aged 16 years or older with informed consent to participate the research, who had no history of upper limb dysfunction due to diseases such as stroke, neuromuscular diseases, musculoskeletal diseases.
2) upper limb dysfunction
Physically stable patients aged 16 years or older with informed consent to participate the research, who suffers from upper limb dysfunction.
Key exclusion criteria Those who have difficulty in maintaining a sitting position for 30 minutes.
Those who have difficulty to follow instructions because of consciousness disorder/ cognitive disorder.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Saitoh
Organization Fujita Health University
Division name Department of Rehabilitation Medicine I,school of Medicine
Zip code
Address 1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL 0562-93-2167
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuki Okochi
Organization Fujita Health University Hospital
Division name Department of Rehabilitation
Zip code
Address 1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL 0562-93-2155
Homepage URL
Email oyuki@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization Fujita Health University
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
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 04 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 Enrolling by invitation
Date of protocol fixation
2016 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 04 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
2017 Year 04 Month 25 Day
Last modified on
2017 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031086

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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