UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039195 |
|---|---|
| Receipt number | R000044698 |
| Scientific Title | Examination of nursing assistance that affects improvement of upper limb motor palsy after stroke |
| Date of disclosure of the study information | 2020/01/20 |
| Last modified on | 2020/07/19 11:12:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of nursing assistance that affects improvement of upper limb motor palsy after stroke
Acronym
Examination of nursing assistance that affects improvement of upper limb motor palsy after stroke
Scientific Title
Examination of nursing assistance that affects improvement of upper limb motor palsy after stroke
Scientific Title:Acronym
Examination of nursing assistance that affects improvement of upper limb motor palsy after stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurosurgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
n acute stroke patients with finger paralysis, the two groups were divided into two groups: a group that underwent normal treatment and rehabilitation (control group) and a group that considered hand washing with running water (intervention group). To clarify the effect in improving motor function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The motor function of the upper limb and fingers on the paralyzed side on the third and seventh days of the onset of stroke is measured with reference to the upper limb / finger items on the Brunstrom stage.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
With regular treatment and regular rehabilitation, motor function of the paralyzed upper limb is measured on the third and seventh days of the onset of stroke. The required measurement time is assumed to be within 15 minutes.
Interventions/Control_2
In addition to the usual treatment and rehabilitation, hand washing is performed once a day with the assistance of researchers. Perform daily for 5 days from the third day of onset. The training will be conducted at the bedside with the person in a wheelchair.
The motor function of the upper limb is measured on the third day after the onset and on the seventh day after the hand washing operation is completed.
Rough motion is assumed to be within 5 minutes at a time.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
atients diagnosed as having a stroke and having upper limb motor paralysis.
Patients who can voluntarily agree to participate in this study.
There must be no complications of the following diseases that affect the test. Poorly controlled heart failure, respiratory dysfunction, paralysis of the shoulder joint dislocation, allergic symptoms to fingers.
Key exclusion criteria
Patients who cannot obtain consent to participate due to consciousness disorders, cognitive decline, and aphasia.
Branch atheromatous disease: A patient diagnosed with BAD and predicted to have progressive paralysis.
Patients who are not authorized by their physician for reasons such as complications of the disease affecting the study.
Patient who declined during the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Minagawa |
Organization
Tokushima University
Division name
Medical and Dental Pharmacy Research Department
Zip code
7708503
Address
3-18-15 Kurahonmachi, Tokushima City
TEL
088-633-7644
minagawa.takako@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Minagawa |
Organization
Tokushima University
Division name
Medical and Dental Pharmacy Research Department
Zip code
7708503
Address
3-18-15 Kurahonmachi, Tokushima City
TEL
088-633-7644
Homepage URL
minagawa.takako@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Funding Source
Organization
Tokushima 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
Tokushima University Hospital Clinical Trial Management Center
Address
2-5-1 Kuramotocho, Tokushima City, Tokushima Prefecture
Tel
088-633-9294
awachiken@tokushima-u.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 20 | 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
| 2020 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2021 | 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
| 2020 | Year | 01 | Month | 18 | Day |
Last modified on
| 2020 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044698
