UMIN-CTR Clinical Trial

Basic information
Public title	Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty
Acronym	Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty
Scientific Title	Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty
Scientific Title:Acronym	Effect of seated side tapping traning on phase coordination index in patient with total knee arthroplasty
Region	Japan

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

Objectives
Narrative objectives1	Evaluate whether seated side tapping training is able to improve phase coordination (PCI) index in patients with TKA.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluate difference of PCI between the intervention group and control group.
Key secondary outcomes	gait speed, knee function

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

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 knee arthroplasty The ability to walk 30 m or more without assistance before TKA.
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	100

Research contact person
Name of lead principal investigator	1st name Hideyuki Middle name Last name Wanaka
Organization	Osaka General Medical Center
Division name	Department of Rehabilitation
Zip code	558-8558
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku Osaka-shi, Osaka, Japan
TEL	06-6692-1201
Email	ceh.2o4l.amrmtsc@gmail.com

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	599-8531
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	Osaka General Medical Center
Institute
Department

Funding Source
Organization	Osaka Prefecture University
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	Osaka General Medical Center
Address	3-1-56, Bandaihigashi, Sumiyoshi-ku Osaka-shi, Osaka, Japan
Tel	06-6692-1201
Email	kyuseisogo@opho.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 06 Month 28 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	100
Results	We found no significant difference in PCI between before (6.73%) and after TKA (6.94%). PCI were significantly correlated with knee extension of the non-operative side and knee pain of the pre-operative side, and knee extension of the non-operative side was selected as independent variable before TKA. However, a significant correlation was found only between PCI and age after TKA.
Results date posted	2020 Year 06 Month 28 Day
Results Delayed	Delay expected
Results Delay Reason	To be published in Journal of the Japanese Physical Therapy Association at a later date.
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 06 Month 17 Day
Date of IRB	2016 Year 01 Month 04 Day
Anticipated trial start date	2017 Year 06 Month 17 Day
Last follow-up date	2019 Year 06 Month 17 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 06 Month 28 Day
Last modified on	2021 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032127