UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a new objective method for assessments of dexterous motor function in patients with cervical myelopathy
Title of the study (Brief title)	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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masao Omori
Organization	Kyorin University School of Medicine
Division name	Department of Orthopedic Surgery
Address	20-2 6choume Shinkawa Mitaka-shi Tokyo-to
TEL	0422475511
Email	omori_masao@hotmail.co.jp

Public contact
Name of contact person	Masao Omori
Organization	Kyorin University School of Medicine
Division name	Department of Orthopedic Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2012 Year 04 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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