UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035849
Receipt number R000040838
Scientific Title Kinematic analysis of gait initiation in Parkinson's disease
Date of disclosure of the study information 2019/02/12
Last modified on 2021/08/27 07:08:55

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Basic information

Public title

Kinematic analysis of gait initiation in Parkinson's disease

Acronym

Kinematic analysis of gait initiation in Parkinson's disease

Scientific Title

Kinematic analysis of gait initiation in Parkinson's disease

Scientific Title:Acronym

Kinematic analysis of gait initiation in Parkinson's disease

Region

Japan


Condition

Condition

Parkinson's disease patients

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The principal aim of the present study was to conduct a kinematic analysis to elucidate anticipatory postural adjustments (APAs) during gait initiation in Parkinson's disease patients.

Basic objectives2

Others

Basic objectives -Others

latency muscle activity,Center of pressure and acceleration movement

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

surface electromyogram and gravity and accelerometer

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Task is gait initiation six times

Interventions/Control_2

Task is gait initiation six times

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

45 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Person is gait without assistance

Key exclusion criteria

Person has Serious higher brain dysfunction and tive dicline cognitive function

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Tomoko
Middle name
Last name Sakai

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Division name

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Zip code

113-8510

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

+818012104673

Email

1781301r@spu.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Onuma

Organization

Tokyo Medical and Dental University

Division name

Graduate School of Medical and Dental Sciences

Zip code

113-8510

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

+818012104673

Homepage URL


Email

1781301r@spu.ac.jp


Sponsor or person

Institute

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JPN


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University

Address

1-5-45 Yushima Bunkyo-ku Tokyo

Tel

0338136111

Email

onuma.reh@tmd.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

2019 Year 02 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications


Number of participants that the trial has enrolled

20

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

Completed

Date of protocol fixation

2019 Year 02 Month 12 Day

Date of IRB

2019 Year 01 Month 15 Day

Anticipated trial start date

2019 Year 10 Month 01 Day

Last follow-up date

2021 Year 06 Month 29 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 02 Month 12 Day

Last modified on

2021 Year 08 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040838


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name