UMIN-CTR Clinical Trial

Basic information
Public title	The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty
Acronym	The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty
Scientific Title	The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty
Scientific Title:Acronym	The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to address the effectiveness of Seated Side Tapping(SST) training, which focuses on the quickness of trunk movement in a seated position, on mobility in THA patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Walking speed of 7 days, 12days, 14 days, 18 days, 52 days, 84 days after surgery.
Key secondary outcomes	Stride time and Coefficient of variability, Timed up & go test, hip and knee isometric muscle strength, Trunk extension endurance, Short physical performance battery, Harris hip score, Passive range of motion.

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	At 2 days after surgery, patients in the SST group carried out SST training in addition to the standard inpatient rehabilitation program. The total time of one set of SST training including preparation was 3 minutes per day.
Interventions/Control_2	The standard inpatient rehabilitation program.
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	Patients who had total hip arthroplasty. Patients who can walk a cane of 10 m or more at preoperative and one week after surgery.
Key exclusion criteria	A participant was excluded if patients had any medical or neurological problem that would affect their ability to complete this trial, such as severe dementia, stroke, cardiac insufficiency, or acute respiratory failure.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name Honma
Organization	Tominaga hospital
Division name	Department of Rehabilitation
Zip code	556-0017
Address	1-4-48, Minatomachi, Naniwa-ku, Osaka city, Osaka prefecture, Japan.
TEL	06-6568-1601
Email	minichan07@hotmail.co.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Iwata
Organization	Osaka Prefecture University
Division name	Graduate School of Comprehensive Rehabilitation
Zip code	583-8555
Address	3-7-30, Habikino,Habikino city, Osaka prefecture, Japan.
TEL	072-950-2111
Homepage URL
Email	minichan07@hotmail.co.jp

Sponsor
Institute	Tominaga hospital
Institute
Department

Funding Source
Organization	Not exist
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	Tominaga hospital
Address	1-4-48, Minatomachi, Naniwa-ku, Osaka city, Osaka prefecture, Japan.
Tel	06-6568-1601
Email	minichan07@hotmail.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	富永病院(大阪府)

Other administrative information
Date of disclosure of the study information	2017 Year 10 Month 02 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	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
Date of IRB	2017 Year 07 Month 04 Day
Anticipated trial start date	2017 Year 07 Month 07 Day
Last follow-up date	2018 Year 09 Month 24 Day
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 02 Day
Last modified on	2020 Year 10 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032001