UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009693
Receipt number R000011365
Scientific Title The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms
Date of disclosure of the study information 2013/01/05
Last modified on 2013/01/04 19:20:05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms

Acronym

The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms

Scientific Title

The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms

Scientific Title:Acronym

The gait assist method for Parkinson's disease patients using mutual synchronization between movement rhythms

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the influence of interactive rhythmic auditory stimulation on instable locomotion function with Parkinson's disease

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The amount of change of the time series feature in stride time

Key secondary outcomes

The mean and the variability of stride time


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Interventions/Control_1

The presentation of the interactive rhythmic auditory stimulation during the walk of Parkinson's disease patients

Interventions/Control_2

The presentation of the fixed-tempo rhythmic auditory stimulation during the walk of Parkinson's disease patients

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

The Parkinson's disease patients who have normal hearing and no dementia and have the locomotion ability of approximately 200 meters long.

Key exclusion criteria

The Parkinson's disease patients who have serious disorder in hearing or cognitive ability.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Miyake

Organization

Tokyo Institute of Technology

Division name

Dept. of Computational Intelligence and Systems Science

Zip code


Address

4259 Nagatsuta, Midori, Yokohama 226-8502 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Institute of Technology

Division name

Dept. of Computational Intelligence and Systems Science

Zip code


Address


TEL


Homepage URL


Email

miyake@dis.titech.ac.jp


Sponsor or person

Institute

Tokyo Institute of Technology, Dept. of Computational Intelligence and Systems Science

Institute

Department

Personal name



Funding Source

Organization

None

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

2013 Year 01 Month 05 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

Completed

Date of protocol fixation

2011 Year 10 Month 07 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 07 Day

Last follow-up date

2012 Year 12 Month 07 Day

Date of closure to data entry

2012 Year 12 Month 17 Day

Date trial data considered complete

2012 Year 12 Month 27 Day

Date analysis concluded

2013 Year 01 Month 04 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 04 Day

Last modified on

2013 Year 01 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011365


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name