UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035101
Receipt number R000040012
Scientific Title Retrospective study on gait disorder of rehabilitation patients
Date of disclosure of the study information 2018/12/12
Last modified on 2018/12/01 22:42:58

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Basic information

Public title

Retrospective study on gait disorder of rehabilitation patients

Acronym

Retrospective study on gait disorder of rehabilitation patients

Scientific Title

Retrospective study on gait disorder of rehabilitation patients

Scientific Title:Acronym

Retrospective study on gait disorder of rehabilitation patients

Region

Japan


Condition

Condition

Neurological diseases and musculoskeletal diseases

Classification by specialty

Neurology Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Although the evaluation of walking using three dimensional motion analysis has made great progress in recent years, it has not been widely used in clinical practice. One of the causes is the difficulty of understanding the clinical significance of the analysis results. In the clinic of rehabilitation, the abnormal walking patterns are presented with the combination of several changes in gait, such as a trunk movement pattern, changes in multiple joint movement. The purpose of this study is to analyze the gait disorder patterns and create a quantitative evaluation model by indexing abnormal gait pattern caused by neurological and musculoskeletal disease, and to develop gait analysis system which contributes to clinical decision making in the real world clinics.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Data of three dimensional motion analysis

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who suffered from neurological or musculoskeletal disease and received gait analysis

Key exclusion criteria

None

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Eiichi Saitoh

Organization

Fujita Health University

Division name

Department of rehabilitation medicine I

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan

TEL

+81-562-93-2167

Email

esaitoh@fujita-hu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiko Mukaino

Organization

Fujita Health University

Division name

Department of rehabilitation medicine I

Zip code


Address

1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan

TEL

+81-562-93-2167

Homepage URL


Email

mmukaino@fujita-hu.ac.jp


Sponsor or person

Institute

Fujita Health University

Institute

Department

Personal name



Funding Source

Organization

Fujita Health University

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 12 Month 12 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

2004 Year 01 Month 04 Day

Date of IRB


Anticipated trial start date

2004 Year 01 Month 04 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

To investigate the medical charts and examination data of the patients who have suffered from central nervous system diseases (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, Parkinson's disease etc.) and bone joint diseases (osteoarthritis, osteoarthritis, rheumatoid arthritis etc.) and were introduced to our hospital rehabilitation department from April 2004 until August 2018.


Management information

Registered date

2018 Year 12 Month 01 Day

Last modified on

2018 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040012


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name