UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000043906
Receipt number R000050143
Scientific Title Quantification of anticipatory postural adjustments evaluation using smartphone
Date of disclosure of the study information 2024/03/31
Last modified on 2021/04/13 11:27:03

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Basic information

Public title

Quantification of anticipatory postural adjustments evaluation using smartphone

Acronym

Quantification of anticipatory postural adjustments evaluation using smartphone

Scientific Title

Quantification of anticipatory postural adjustments evaluation using smartphone

Scientific Title:Acronym

Quantification of anticipatory postural adjustments evaluation using smartphone

Region

Japan


Condition

Condition

control, patients with Parkinson's disease, patients with stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Quantification of anticipatory postural adjustments evaluation using smartphone

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

acceleration

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

45 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Regarding the recruitment of the participants, the patients with PD and stroke were selected from the outpatients of our rehabilitation facility, and the healthy elderly controls with no medical history were recruited from around our neighborhood. The inclusion criteria required participants in each group to be capable of unassisted walking, have a score of at least 24 on the Mini-Mental State Examination (MMSE), and be free of marked limited range of motion of the ankles.

Key exclusion criteria

People unable to readily understand the task, people with a visual disorder, and people with sensory impairments were excluded.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Tomoko
Middle name
Last name Sakai

Organization

Tokyo Medical and Dental University Graduate School

Division name

Department of Rehabilitation Medicine

Zip code

113-8510

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

0338136111

Email

t_sakai.orth@tmd.ac.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Onuma

Organization

Tokyo Medical and Dental University Graduate School

Division name

Department of Rehabilitation Medicine

Zip code

349-0142

Address

1-5-45 Yushima Bunkyo-ku Tokyo

TEL

+81487652525

Homepage URL


Email

1781301r@spu.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University Graduate School

Institute

Department

Personal name



Funding Source

Organization

Other

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

Tokyo Medical and Dental University Graduate School

Address

1-5-45 Yushima Bunkyo-ku Tokyo

Tel

+818012104673

Email

1781301r@spu.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

2024 Year 03 Month 31 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

Preinitiation

Date of protocol fixation

2021 Year 04 Month 13 Day

Date of IRB


Anticipated trial start date

2021 Year 04 Month 13 Day

Last follow-up date

2024 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Before the start


Management information

Registered date

2021 Year 04 Month 13 Day

Last modified on

2021 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050143


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name