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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046223
Receipt No. 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

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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
Institute Kio University
Institute
Department

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
URL(English) 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


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