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

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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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name