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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023796
Receipt No. R000027418
Scientific Title The research of effect in the novel back support set for elderly individuals
Date of disclosure of the study information 2016/09/01
Last modified on 2016/08/28

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Basic information
Public title The research of effect in the novel back support set for elderly individuals
Acronym The comparison of posture between standard type wheelchair and standard type wheelchair with the novel back support set.
Scientific Title The research of effect in the novel back support set for elderly individuals
Scientific Title:Acronym The comparison of posture between standard type wheelchair and standard type wheelchair with the novel back support set.
Region
Japan

Condition
Condition We don't limit for individuals by type of disease. one of our inclusion criteria is using wheelchair in daily living.
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this research is to clarify that whether the novel back support set has same function as custom back support wheelchair.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The cervical, trunk, shoulder flexion, and elevation angles of the upper extremity in the sagittal plane.
Key secondary outcomes Buttock and back support pressure distributions were measured.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 This research is crossed-over design. We use two wheelchairs as intervention. All individuals sit both wheelchairs (Wheelchair A and Wheelchair B). I perform experiment at random.
Trial 1: Wheelchair A, next, Wheelchair B

Both wheelchairs are standard type wheelchair. Wheelchair B is attached novel back support set.
Interventions/Control_2 Trial 2: Wheelchair B , next, Wheelchair A
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We define two inclusion criteria. One is authorized long term care insurance. Another is using wheelchair in daily living.
Key exclusion criteria We define an exclusion criteria. We exclude the individuals who could not understand the content of research.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Goda Hiroshi
Organization Japan Health Care College
Division name Health and medical faculty
Zip code
Address Enid city Megumino Nishi -6 chome17-3
TEL 0123-29-3171
Email h_goda@nihoniryo-c.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sugihara Akihito
Organization Japan Health Care College
Division name secretariat
Zip code
Address Sapporo city kiyota ward sine 434-1
TEL 011-885-7711
Homepage URL
Email a_sugihara@nihoniryo-c.ac.jp

Sponsor
Institute Japan Health Care College
Institute
Department

Funding Source
Organization Japan Health Care College
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
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
2016 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The novel back support set(NBS) improved forward head posture and movement of the upper extremity in elderly disabled individuals. NBS was shown to be a suitable alternative to the custom wheelchair.
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
2014 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 28 Day
Last modified on
2016 Year 08 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027418

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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