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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028188
Receipt No. 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

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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
Institute Tokushima University
Institute
Department

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
URL(English) https://upload.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


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