UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Usefulness of upper limb function training to improve physical activity in THA and TKA patients early postoperatively
Title of the study (Brief title)	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	Ryouta Kamimura
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Rehabilitation
Address	Chiba prefecture Ichikawa City Sugano 5-11-13
TEL	0473220151
Email	zz_er15_21@yahoo.co.jp

Public contact
Name of contact person	Ryouta Kamimura
Organization	Tokyo Dental College Ichikawa General Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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