UMIN-CTR Clinical Trial

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