UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016326 |
|---|---|
| Receipt number | 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 17:52:42 |
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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
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
tsota@grape.med.tottori-u.ac.jp
Sponsor or person
Institute
Division of rehabilitation, Tottori univercity hospital.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018946
