UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000022865
Receipt number	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 17:35:21

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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

patients with cervical myelopathy

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

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

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 or person

Institute

Kyorin University School of Medicine

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Value
https://center6.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