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
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
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
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
