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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016326
Receipt No. R000018946
Scientific Title Effects of body weight supported walking exersise using lower body positive pressure device on physical performance in elderly with leg pain
Date of disclosure of the study information 2015/02/01
Last modified on 2016/08/01

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Basic information
Public title Effects of body weight supported walking exersise using lower body positive pressure device on physical performance in elderly with leg pain
Acronym Walking exercise with weight supported using LBPP device
Scientific Title Effects of body weight supported walking exersise using lower body positive pressure device on physical performance in elderly with leg pain
Scientific Title:Acronym Walking exercise with weight supported using LBPP device
Region
Japan

Condition
Condition Elderly partisipants with knee pain
permitting the diagnosostic of osteorthritis.
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effectivity of walking exercise by lower body positive pressure in elderly participants with knee pain.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Japanese knee osteoarthritis measure(JCOM)
Japanese orthopaedic association score(JOA score)
Franchay activity index(FAI)
Lower extremity functional scale
Key secondary outcomes knee extention muscle strength
range of motion of knee and ankle joint
waking speed
one leg stance time

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 body weight supported walking exercise using lower body positive pressure device
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
55 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria pertisipants having previous history of osteoarthritis and common everyday knee pain, who haven't undergo operation.
Key exclusion criteria partisipants having a past history of cardiopulmonary disease,blood disorder, ASO, aortic aneurysm or aoltic dissection, neuromuscler disease, being
not able to stand, having a pain in addition to the knee joint, or dimented.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Sota
Organization Tottori university hosipital
Division name Rehabilitation division
Zip code
Address Nishi-cho 36-1, Yonago, Tottori, Japan
TEL 0859-38-6862
Email tsota@grape.med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Sota
Organization Tottori university hospital
Division name Rehabilitation division
Zip code
Address Nishi-cho 36-1, Yonago, Tottori, Japan
TEL 0859-38-6862
Homepage URL
Email tsota@grape.med.tottori-u.ac.jp

Sponsor
Institute Division of rehabilitation, Tottori univercity hospital.
Institute
Department

Funding Source
Organization JSPS
KAKEN
Organization
Division
Category of Funding Organization Japanese Governmental office
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 鳥取大学医学部附属病院(鳥取県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 01 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 No longer recruiting
Date of protocol fixation
2015 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 18 Day
Last follow-up date
2015 Year 07 Month 30 Day
Date of closure to data entry
2015 Year 07 Month 30 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 01 Month 24 Day
Last modified on
2016 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018946

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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