UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037083 |
|---|---|
| Receipt number | R000042254 |
| Scientific Title | The factors for the Gait related self efficacy in patients with knee osteoarthritis |
| Date of disclosure of the study information | 2019/08/01 |
| Last modified on | 2021/06/08 07:14:35 |
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Basic information
Public title
The factors for the Gait related self efficacy in patients with knee osteoarthritis
Acronym
The factors for the Gait related self efficacy in patients with knee osteoarthritis
Scientific Title
The factors for the Gait related self efficacy in patients with knee osteoarthritis
Scientific Title:Acronym
The factors for the Gait related self efficacy in patients with knee osteoarthritis
Region
| Japan |
Condition
Condition
patients with knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to reveal the ralationship between gait related self efficacy and physical function, knee pain, health related quality of life, life space.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese-modified Gait efficacy scale
Pain catasrophizing scale
Life space assesment
Range of motion and muscle strength in knee joint
knee joint pain
gait function
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individual who Doctor diagnosed knee osteoarthritis and be possible walking.
Key exclusion criteria
Individual who has no history of orthopedic disease that has obvious influence on gait function other than knee osteoarthritis
Individual who have no notable items in neurology or physiology that clearly affect gait function
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Mawarikado |
| Middle name | |
| Last name | Yuya |
Organization
Kashiba Asahigaoka Hospital
Division name
Department of Rehabilitation
Zip code
639-0265
Address
839 Kaminaka, Kashiba City, Nara Prefecture
TEL
0745-77-8101
b9972384@kio.ac.jp
Public contact
Name of contact person
| 1st name | Mawarikado |
| Middle name | |
| Last name | Yuya |
Organization
Kashiba Asahigaoka Hospital
Division name
Department of Rehabilitation
Zip code
639-0265
Address
839 Kaminaka, Kashiba City, Nara Prefecture
TEL
0745-77-8101
Homepage URL
b9972384@kio.ac.jp
Sponsor or person
Institute
Kashiba Asahigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Graduate school of Kio university
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
Kashiba Asahigaoka Hospital
Address
839 Kaminaka, Kashiba City, Nara Prefecture
Tel
0745-77-8101
b9972384@kio.ac.jp
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
| 2019 | Year | 08 | 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
67
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
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collected during the period to March 31, 2121, will be used as a retrospective study.
Management information
Registered date
| 2019 | Year | 06 | Month | 16 | Day |
Last modified on
| 2021 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042254
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
