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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013178
Receipt No. R000015367
Scientific Title Effects of a spinal orthosis on posture, balance, and walking ability in kyphotic patients
Date of disclosure of the study information 2014/02/17
Last modified on 2017/08/17

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Basic information
Public title Effects of a spinal orthosis on posture, balance, and walking ability in kyphotic patients
Acronym Immediate effect of thoracolumbar orthoses .
Scientific Title Effects of a spinal orthosis on posture, balance, and walking ability in kyphotic patients
Scientific Title:Acronym Immediate effect of thoracolumbar orthoses .
Region
Japan

Condition
Condition kyphosis
Classification by specialty
Geriatrics Orthopedics Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the immediate effects of a spinal orthosis on posture, balance, and walking ability in kyphotic patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes walking ability
Key secondary outcomes balance ability
posture

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 spinal orthosis
Interventions/Control_2
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
90 years-old >=
Gender Male and Female
Key inclusion criteria kyphosis
back pain
The patient who can walk.
Key exclusion criteria The patient who can not walk.
The patient who don't agree with this study.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Enishi
Organization Tokushima University Hospital
Division name Department of Rehabilitation Medicine
Zip code
Address 2-50-1 Kuramoto, Tokushima
TEL 0886337240
Email enishi.tetsuya@tokushima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Enishi
Organization Tokushima University Hospital
Division name Rehabilitation Medicine
Zip code
Address 2-50-1 Kuramoto, Tokushima
TEL 0886337240
Homepage URL
Email enishi.tetsuya@tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization Tokushima University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 1850
Org. issuing International ID_1 Tokushima University Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 徳島大学病院(徳島県)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 17 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 Completed
Date of protocol fixation
2014 Year 02 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 17 Day
Last follow-up date
2015 Year 08 Month 31 Day
Date of closure to data entry
2015 Year 08 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 17 Day
Last modified on
2017 Year 08 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015367

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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