UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046223
Receipt number R000052751
Scientific Title classification of upper limb activity in daily life of stroke patients -Using a triaxial accelerometer-
Date of disclosure of the study information 2021/11/29
Last modified on 2021/11/29 20:44:55

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Basic information

Public title

classification of upper limb activity in daily life of stroke patients
-Using a triaxial accelerometer-

Acronym

classification of upper limb activity in daily life of stroke patients
-Using a triaxial accelerometer-

Scientific Title

classification of upper limb activity in daily life of stroke patients
-Using a triaxial accelerometer-

Scientific Title:Acronym

classification of upper limb activity in daily life of stroke patients
-Using a triaxial accelerometer-

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the measurements of upper limb activity obtained from accelerometers in hemiplegic stroke patients and the distribution characteristics according to the severity of motor paralysis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Value obtained from accelerometer.
Bilateral Magnitude,Magnitude Ratio

FMA

Key secondary outcomes

FIM,NIHSS,mAS,FMA,ARAT,MAL,MMSE,SIS


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

20 years-old <=

Age-upper limit

100 years-old >

Gender

Male and Female

Key inclusion criteria

Patients with hemiplegia due to cerebral vascular disease or brain injury such as head trauma, and who have the language or communication ability to perform each evaluation battery.

Key exclusion criteria

Patients with upper extremity-related diseases such as upper extremity fracture, consciousness disorder, or serious cardiac disease.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Yuji
Middle name
Last name Minamikawa

Organization

Kio University

Division name

Graduate School of Health Science

Zip code

635-0832

Address

Koryo-cho, Kitakatsuragi-gun, Nara

TEL

+81-74-554-1601

Email

y1m18sud@gmail.com


Public contact

Name of contact person

1st name Yuji
Middle name
Last name Minamikawa

Organization

Kio University

Division name

Graduate School of Health Science

Zip code

635-0832

Address

Koryo-cho, Kitakatsuragi-gun, Nara

TEL

+81-74-554-1601

Homepage URL


Email

y1m18sud@gmail.com


Sponsor or person

Institute

Kio University

Institute

Department

Personal name



Funding Source

Organization

Kio 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

Kio University

Address

Koryo-cho, Kitakatsuragi-gun, Nara

Tel

+81-74-554-1601

Email

y1m18sud@gmail.com


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

2021 Year 11 Month 29 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 11 Month 01 Day

Date of IRB


Anticipated trial start date

2022 Year 01 Month 15 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: Cross-sectional study
Method of recruitment: Hemiplegic stroke patients who are hospitalized in the recovery phase and who do not have upper limb related diseases or serious cardiac diseases
Measurements: Bilateral magnitude and magnitude ratio calculated from the values obtained from the accelerometer and FMA


Management information

Registered date

2021 Year 11 Month 29 Day

Last modified on

2021 Year 11 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name