UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000030209