UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023796
Receipt number 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 12:29:16

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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 or person

Institute

Japan Health Care College

Institute

Department

Personal name



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

Value
https://center6.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