UMIN-CTR Clinical Trial

Basic information
Public title	Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Acronym	Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Scientific Title	Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Scientific Title:Acronym	Development of a clinical reaching assessment scale for patients with hemiparetic stroke-prospective study-
Region	Japan

Condition
Condition	patients with hemiparetic stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify reliability, validity, and responsiveness of the reaching assessment scale which we developed.
Basic objectives2	Others
Basic objectives -Others	Psychometric properties
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Inter-rater reliability Intra-rater reliability Concurrent validity with the severity of upper-extremity motor paralysis, spasticity and so on. responsiveness
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Over 20 years old 2) Hemiparesis due to unilateral hemispheric lesion 3) With motor dysfunction of upper extremity 4) 150 days and over from stroke onset 5) Can keep sitting by oneself 6) Without higher cortical dysfunctions that hinder clinical assessment 7) Range of motion of the affected upper extremity : shoulder flexion over 90 degrees,elbow extension over -40 degrees,finger extension over 0 degree 8) Without severe pain of the affected upper extremity 9) Without severe deep sensory disturbance
Key exclusion criteria	Contraindications to upper extremity exercise (details as described below) 1)Severe heart diseases such as unstable angina, recent onset myocardial infarction, decompensated congestive heart failure, acute core pulmonare, poorly controlled arrythmia, severe aortic valvular disease, active myocarditis, pericarditis and so on. 2)Poorly controlled hypertension 3)Acute systemic disease or fever 4)Acute pulmonary embolism, cor pulmonale, severe pulmonary hypertension 5)Severe hepatic dysfunction and renal dysfunction 6)Orthopedic diseases which may disturb upper extremity functions 7)With severe cognitive and mental disorders 8)With metabolic disorders such as acute thyroiditis
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Meigen Liu
Organization	Keio University School of Medicine, Japan
Division name	Department of Rehabilitation Medicine
Zip code
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL	03-5363-3833
Email	meigenliukeio@mac.com

Public contact
1st name of contact person	1st name Middle name Last name Atsuko Nishimura
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Zip code
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL	03-5363-3833
Homepage URL
Email	atsukohorie7@gmail.com

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	慶應義塾大学医学部リハビリテーション医学教室

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 12 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	Completed
Date of protocol fixation	2017 Year 06 Month 09 Day
Date of IRB	2017 Year 09 Month 11 Day
Anticipated trial start date	2017 Year 09 Month 11 Day
Last follow-up date	2019 Year 03 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	classification of sex, age, disease type of stroke, lesions caused by stroke, medical treatment, disease duration, motor dysfunction, sensory dysfunction, spasticity, range of motion, higher brain dysfunction and so on

Management information
Registered date	2017 Year 06 Month 09 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031737