UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The research of effect in the novel back support set for elderly individuals
Title of the study (Brief title)	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	Goda Hiroshi
Organization	Japan Health Care College
Division name	Health and medical faculty
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	Sugihara Akihito
Organization	Japan Health Care College
Division name	secretariat
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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