UMIN-CTR Clinical Trial

Basic information
Public title	Validity, reliability and reactivity of the sensory measurements in post stroke patients.
Acronym	Validity, reliability and reactivity of the sensory measurements in post stroke patients.
Scientific Title	Validity, reliability and reactivity of the sensory measurements in post stroke patients.
Scientific Title:Acronym	Validity, reliability and reactivity of the sensory measurements in post stroke patients.
Region	Japan

Condition
Condition	stroke
Classification by specialty	Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examin reliability, validity and reactivity evaluating SWM test and thumb-localizing test in post stroke patients with hemiparesis.
Basic objectives2	Others
Basic objectives -Others	To examin reliability, validity and reactivity evaluating SWM test and thumb-localizing test in post stroke patients with hemiparesis.
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	light touch and pressure sensation of paretic upper extrimity.
Key secondary outcomes	motor function set of Stroke Impairment Assessment Set, SEP, Fugl-Mayer Assessment, ROM, modified Ashworth Scale.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	SWM and thumb-localizing test is selected for those who are admitted to our hospital and recieving rehabilitation. SWM test is carried out as follows according to the manual. Place the the paretic forearm on the table, and close the curtain in front of patients. Let them close the eyes, and instruct - when you feel the filament, please say "yes". Then slowly push the filament on their fingers until they bend 90 degrees. Leave it for 1.5 seconds and slowly release. When the filament gauge is 1.65 to 4.08, this is performed three times. 4.17 to 6.65, it is performed once. Even if it is correct just once ,it is positive. The filament is selected from 2.83, and it gradually becomes thick. If 2.83 is cleared, try it with thinner ones. Thumb-localizing test is carried out as follows. The examiner grips paretic fingers of the patient holding only the thumb to the outside and fixes the upper limb in an arbitrary position. After fixation, the examiner instructs to relax this fixed limb and to pinch the tip of the thumb with sound side.Next, let the patient close their eyes, the examiner passively fixes the patient's limb and fixes it. And order that pinch the thumb tip of the fixed limb as with the preliminary test. Repeat this several times. -Reliability verification- *Intra rater reliability: The same examiner performs this set at least 2 hours after first set within 2 days.*Inter rater reliability: The examiner B performs this set for the same patient on the same day as the examiner A's evaluation. -Verification of validity-From the correlation with SIAS sensory items and SEP, we verify the validity as an evaluation method of upper limb sensory function. -Verification of responsiveness- Clinical evaluation, sensory evaluation on sound side and affected side is conducted on the first day and last day of rehabilitation. From the correlation with the change of the result, the reactivity is verified.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Men and women ages 20 to 80 years old. Patients with upper limb motor paralysis due to stroke. Sitting position can be maintained by oneself.
Key exclusion criteria	Those with severe heart disease: unstable angina, accute myocardial infarction, decompensated congestive heart failure, acute pulmonary heart, arrhythmia with poor control, severe aortic valve stenosis, active Myocarditis, endocarditis etc. Persons with severe cognitive impairment, severe mental illness Persons judged inappropriate by a doctor for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kawakami Middle name Last name Michiyuki
Organization	Keio university
Division name	department of rehabilitation medicine
Zip code	1600016
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	(03)3353-1211
Email	keiorehab@gmail.com

Public contact
Name of contact person	1st name Kawakami Middle name Last name Michiyuki
Organization	Keio university
Division name	department of rehabilitation medicine
Zip code	1600016
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	(03)3353-1211
Homepage URL
Email	keiorehab@gmail.com

Sponsor
Institute	Keio university
Institute
Department

Funding Source
Organization	Keio University
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	Keio University Hospital
Address	35 Shinanomachi, Shinjyuku-ku, Tokyo
Tel	(03)3353-1211
Email	med-rinri-jimu@adst.keio.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	慶應義塾大学病院(東京都)

Other administrative information
Date of disclosure of the study information	2017 Year 09 Month 06 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 12 Day
Date of IRB	2017 Year 09 Month 06 Day
Anticipated trial start date	2017 Year 09 Month 19 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 09 Month 05 Day
Last modified on	2020 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033154