UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028188
Receipt number R000032267
Scientific Title Effect of manual bathing on the range of joint motion for hemiplegia of patients with acute stroke
Date of disclosure of the study information 2017/07/12
Last modified on 2018/01/24 10:54:13

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Basic information

Public title

Effect of manual bathing on the range of joint motion for hemiplegia of patients with acute stroke

Acronym

Verification of hand bath effect on hemiplegia

Scientific Title

Effect of manual bathing on the range of joint motion for hemiplegia of patients with acute stroke

Scientific Title:Acronym

Verification of hand bath effect on hemiplegia

Region

Japan


Condition

Condition

Stroke hemiplegia patient

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine
Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For the hemiplegic patients due to stroke in the acute phase, the bathing is continued for 5 days and the change of the range of motion of the fingers and wrist joints is verified

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Patients with upper limb paralysis begin contracture of the wrist joints and finger joints from early onset. Hypothesis was made that continued hand bathing could prevent joint contracture. We considered that the effectiveness of hand bathing for preventing contracture can be demonstrated by measuring changes in the range of joint movement (DIP, PIP, MP joint, wrist joint) of the treated group and the control group.

Key secondary outcomes

Changing relaxation effect, pain and numbness by hand bath


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

Maneuver

Interventions/Control_1

Continue hand bathing for 5 days. Evaluation of the range of joint motion for 5 days. Motor paralysis evaluation on the first day and last day.

Interventions/Control_2

With ordinary nursing care only, we do not do hand bathing for 5 days. Evaluation of the range of joint motion for 5 days. Motor paralysis evaluation on the first day and last day.

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

50 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Patients with stroke and hemiplegia
(2) Patients who can take a sitting posture for 1 hour or more within 3 weeks after 1 week after onset

Key exclusion criteria

(1) Severe patient like life-threatening
(2) Patients with Severe Consciousness Disorder
(3) There are complications. Or a patient who may cause complications.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ayako Tmura

Organization

Tokushima University

Division name

Department of Medical Treatment Recovery Care Nursing

Zip code


Address

18-15 Kuramotocho 3 Tokushima

TEL

088-633-9036

Email

tamura@medsci.tokushima-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukari Hisaka

Organization

Tokushima University

Division name

Department of Medical Treatment Recovery Care Nursing

Zip code


Address

18-15 Kuramotocho 3 Tokushima

TEL

088-633-7613

Homepage URL


Email

hisaka@medsci.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


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



Other administrative information

Date of disclosure of the study information

2017 Year 07 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

Preinitiation

Date of protocol fixation

2017 Year 07 Month 12 Day

Date of IRB


Anticipated trial start date

2017 Year 07 Month 12 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry

2018 Year 03 Month 31 Day

Date trial data considered complete

2018 Year 03 Month 31 Day

Date analysis concluded

2018 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 07 Month 11 Day

Last modified on

2018 Year 01 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032267


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name