UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026305 |
|---|---|
| Receipt number | 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 22:49:43 |
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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
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
tanikawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030209
