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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029392
Receipt No. R000032001
Scientific Title The effect of high velocity trunk exercise on gait ability of patients after total hip arthroplasty
Date of disclosure of the study information 2017/10/02
Last modified on 2019/02/18

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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
Middle name
Last name Keisuke Honma
Organization Tominaga hospital
Division name Department of Rehabilitation
Zip code
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
Middle name
Last name Akira Iwata
Organization Osaka Prefecture University
Division name Graduate School of Comprehensive Rehabilitation
Zip code
Address 3-7-30, Habikino,Habikino city, Osaka prefecture, Japan.
TEL 072-950-2111
Homepage URL
Email iwata@rehab.osakafu-u.ac.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
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 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
Anticipated trial start date
2017 Year 07 Month 07 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 02 Day
Last modified on
2019 Year 02 Month 18 Day


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

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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