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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000022865
Receipt No. R000026239
Scientific Title Development of a new objective method for assessments of dexterous motor function in patients with cervical myelopathy
Date of disclosure of the study information 2016/07/01
Last modified on 2016/06/23

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Basic information
Public title Development of a new objective method for assessments of dexterous motor function in patients with cervical myelopathy
Acronym Development of a new objective method for assessments of dexterous motor function in patients with cervical myelopathy
Scientific Title Development of a new objective method for assessments of dexterous motor function in patients with cervical myelopathy
Scientific Title:Acronym Development of a new objective method for assessments of dexterous motor function in patients with cervical myelopathy
Region
Japan

Condition
Condition patients with cervical myelopathy
Classification by specialty
Orthopedics Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to evaluate the dexterity motor function in the cervical myelopathy patients in detail and objectively, we analyze the exercise that grip and elevate a small object from both sides of kinematics and mechanics.We find the inspection items with the significant difference between healthy subjects and cervical myelopathy patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Development of an objective and detailed method for assessments of dexterous motor function in patients with cervical myelopathy
Key secondary outcomes We predict post operative convalesence of the cervical myelopathy patients by analysing the examination of elaborate exercise function of cervical myelopathy patients at 2 weeks after operation.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy subjects with no neurological symptoms in the past and cervical myelopathy patients
Key exclusion criteria Subjects with neurological symptoms in the past are excluded from healthy subjects
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Omori
Organization Kyorin University School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 20-2 6choume Shinkawa Mitaka-shi Tokyo-to
TEL 0422475511
Email omori_masao@hotmail.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masao Omori
Organization Kyorin University School of Medicine
Division name Department of Orthopedic Surgery
Zip code
Address 20-2 6choume Shinkawa Mitaka-shi Tokyo-to
TEL 0422475511
Homepage URL
Email omori_masao@hotmail.co.jp

Sponsor
Institute Kyorin University School of Medicine
Institute
Department

Funding Source
Organization Kyorin University School of Medicine
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
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
2016 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2012 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The task to evalutate the dexterity motion is to reach for the small box, pick up by thumb and index finger, and hold the box 3 seconds.
We change the surface of the small box (sand paper, suede, and silk).
Subjects underwent this task 10 times.
We measured the following items.

1)Operating time from the start of operation until fingers touch the object
2)The moving distance of the hand from the start of operation to the object contact
3)The maximum distance between thumb and index finger during reaching movement to the object
4)Time until the maximum distance between thmb and index finger
5)The maximum gripping force in the object holding
6)The average gripping force of 3 seconds of object-holding

Management information
Registered date
2016 Year 06 Month 23 Day
Last modified on
2016 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026239

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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