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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026305
Receipt No. R000030209
Scientific Title Developing a measuring instrument for spasticity and study for its usefulness in healthy subjects and stroke patients
Date of disclosure of the study information 2017/02/25
Last modified on 2019/08/30

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Basic information
Public title Developing a measuring instrument for spasticity and study for its usefulness in healthy subjects and stroke patients
Acronym Developing a measuring instrument for spasticity
Scientific Title Developing a measuring instrument for spasticity and study for its usefulness in healthy subjects and stroke patients
Scientific Title:Acronym Developing a measuring instrument for spasticity
Region
Japan

Condition
Condition Healthy, Stroke, Spinal cord injury
Classification by specialty
Orthopedics Neurosurgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine usefulness in the clinical settings and validity of a measuring instrument for spasticity that was developed IMASEN electric industrial co., ltd.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ankle joint resistance torque, muscle tone at rest using Modified Ashworth Scale, passive ankle joint motion range, Foot-pat test
Key secondary outcomes vital sign

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 Ankle joint is moved passively by a measuring instrument
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy: no history of orthopedic and CNS disease
Patients: diagnosed CNS disease
Key exclusion criteria Health condition is unstable
Do not understand an instruction
History of orthopedic disease
Severe limitation of the ankle joint
Other patients with an investigator's decision
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Eiichi
Middle name
Last name Saitoh
Organization Fujita Health University
Division name School of medicine
Zip code 470-1192
Address 1-98, Dengakugakubo, Toyoake, Aichi
TEL 0562-95-2906
Email rehabmed@fujita-hu.ac.jp

Public contact
Name of contact person
1st name Hiroki
Middle name
Last name Tanikawa
Organization Fujita Health University
Division name School of health sciences
Zip code 470-1192
Address 1-98, Dengakugakubo, Toyoake, Aichi
TEL 0562939000
Homepage URL
Email tanikawa@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for research promotion and support
Address 1-98, Dengakugakubo, Toyoake, Aichi
Tel 0562-93-2865
Email f0irb@fujita-hu.ac.jp

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 02 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 Open public recruiting
Date of protocol fixation
2016 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 02 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 02 Month 25 Day
Last modified on
2019 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030209

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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