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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040309
Receipt No. R000045990
Scientific Title Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients:A pilot study
Date of disclosure of the study information 2020/05/05
Last modified on 2020/12/31

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Basic information
Public title Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients
Acronym Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients
Scientific Title Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients:A pilot study
Scientific Title:Acronym Effect of Rehabilitation Based on Behavior Modification Theory for Elderly Knee Osteoarthritis Patients
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to evaluate the effectiveness of a rehabilitation approach based on the theory of behavior modification for elderly patients with knee osteoarthritis based on the basic information (Gender, age, complications, height, weight), HRQOL, instrumental ADL (Instrumental Activities of Daily Living: IADL), fear of falling, and depression, and to examine the effectiveness of a rehabilitation probe based on the theory of behavior modification for patients with knee osteoarthritis aged 65 years and older who underwent rehabilitation in our hospital.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HRQOL score
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 behavioral modification theory
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
65 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria 1)A Case of Conservative Treatment for Knee Osteoarthritis after Rehabilitation in our hospital
2)Age: 65 years or older
3)Gender: both sexes
4)After sufficient informed consent to participate in this study, a voluntary written consent was obtained from the research subjects themselves.
Key exclusion criteria 1)When a research subject requests to decline participation in a study
2)If the research director decides that the subject person should be excluded for other reasons
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takako
Middle name
Last name Nagai
Organization Nihon University Hospital
Division name Orthpedic surgery
Zip code 1018309
Address 1-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
TEL 0332931711
Email ntnyf092@yahoo.co.jp

Public contact
Name of contact person
1st name Takako
Middle name
Last name Nagai
Organization Nihon University hospital
Division name Orthpedic surgery
Zip code 1018309
Address 1-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
TEL 0332931711
Homepage URL
Email ntnyf092@yahoo.co.jp

Sponsor
Institute Nihon University hospital
Institute
Department

Funding Source
Organization Nihon University hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nihon University hospital
Address 1-6, Kandasurugadai, Chiyoda-ku, Tokyo, Japan
Tel 0332931711
Email ntnyf092@yahoo.co.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
2020 Year 05 Month 05 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 Open public recruiting
Date of protocol fixation
2020 Year 04 Month 09 Day
Date of IRB
2020 Year 04 Month 09 Day
Anticipated trial start date
2020 Year 05 Month 01 Day
Last follow-up date
2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 05 Day
Last modified on
2020 Year 12 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045990

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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