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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029560
Receipt No. R000033773
Scientific Title Usefulness of upper limb function training to improve physical activity in THA and TKA patients early postoperatively
Date of disclosure of the study information 2017/10/16
Last modified on 2017/10/15

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Basic information
Public title Usefulness of upper limb function training to improve physical activity in THA and TKA patients early postoperatively
Acronym Usefulness of upper limb function training to improve physical activity in THA and TKA patients early postoperatively
Scientific Title Usefulness of upper limb function training to improve physical activity in THA and TKA patients early postoperatively
Scientific Title:Acronym Usefulness of upper limb function training to improve physical activity in THA and TKA patients early postoperatively
Region
Japan

Condition
Condition Osteoarthritis of the Knee Osteoarthritis of the Hip
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, voluntary training using upper limbs is carried out for patients early after TKA or THA under non-monitoring in their own room in addition to normal rehabilitation group (hereinafter referred to as normal group) and normal rehabilitation (Hereinafter referred to as self-directed train group) and measures the amount of physical activity.The rates of increase in physical activity before and after toilet gait are compared for both the regular group and the independent tray group, and the voluntary training of the upper limb is compared with the physical activity amount of the day In order to verify the effect.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measure the amount of physical activity from the day after surgery until discharge.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Groups performing normal rehabilitation after TKA or THA surgery.
Interventions/Control_2 In addition to rehabilitation after TKA or THA surgery, a group to conduct voluntary training using upper limbs
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria From the approval of the ethics review committee until March 31, 2018, I was hospitalized at the Tokyo Dental College Ichikawa General Hospital, after THA or TKA was done, rehabilitation was prescribed and agreed to this research To be a case.
Key exclusion criteria Patients with postoperative complications, patients with difficulty in measuring physical activity level due to cognitive decline.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryouta Kamimura
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Rehabilitation
Zip code
Address Chiba prefecture Ichikawa City Sugano 5-11-13
TEL 0473220151
Email zz_er15_21@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryouta Kamimura
Organization Tokyo Dental College Ichikawa General Hospital
Division name Department of Rehabilitation
Zip code
Address Chiba prefecture Ichikawa City Sugano 5-11-13
TEL 0473220151
Homepage URL
Email zz_er15_21@yahoo.co.jp

Sponsor
Institute Tokyo Dental College Ichikawa General Hospital Department of Rehabilitation
Institute
Department

Funding Source
Organization none
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
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 16 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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 17 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 15 Day
Last modified on
2017 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033773

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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