UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012567
Receipt number R000014701
Scientific Title A preliminary study of in home posture evaluation and visual feedback training to improve posture with a Kinect based system in patients with Parkinson's disease
Date of disclosure of the study information 2013/12/12
Last modified on 2015/06/12 09:21:10

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Basic information

Public title

A preliminary study of in home posture evaluation and visual feedback training to improve posture with a Kinect based system in patients with Parkinson's disease

Acronym

In home posture evaluation and visual feedback training with a Kinect-based system in Parkinson's disease

Scientific Title

A preliminary study of in home posture evaluation and visual feedback training to improve posture with a Kinect based system in patients with Parkinson's disease

Scientific Title:Acronym

In home posture evaluation and visual feedback training with a Kinect-based system in Parkinson's disease

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate preliminarily the feasbility of in home posture evaluation and visual feedback training with a Kinect based system and the effects of visualfeedback training in patients with Parkinson's disease

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Trunk flexion angle and trunk lateral flexion angle

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

Visual feedback training

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

1.Hoehn and Yahr scale is less than, or equal to 4
2.With postural abnormalities
3.can stand unassissted more than 5 minutes

Key exclusion criteria

1. History of other neurological disorders or severe orthopedic disease

Target sample size

7


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yohei Okada

Organization

Kio university

Division name

Department of Physical Therapy, Faculty of Health Science

Zip code


Address

4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN

TEL

+81-745-54-1601

Email

y.okada@kio.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yohei Okada

Organization

Kio University

Division name

Department of Phisical Therapy, Faculty of Health Science

Zip code


Address

4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN

TEL

+81-745-54-1601

Homepage URL


Email

y.okada@kio.ac.jp


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

JAPAN


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 12 Month 12 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

Suspended

Date of protocol fixation

2013 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 01 Day

Last follow-up date

2015 Year 03 Month 01 Day

Date of closure to data entry

2015 Year 12 Month 01 Day

Date trial data considered complete

2016 Year 01 Month 01 Day

Date analysis concluded

2016 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 12 Day

Last modified on

2015 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014701