UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029009 |
|---|---|
| Receipt number | R000033154 |
| Scientific Title | Validity, reliability and reactivity of the sensory measurements in post stroke patients. |
| Date of disclosure of the study information | 2017/09/06 |
| Last modified on | 2020/02/18 10:31:17 |
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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
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
keiorehab@gmail.com
Sponsor or person
Institute
Keio university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033154
