UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of sensory level neuromuscular electrical stimulation in patients after Total knee arthroplasty : a randomized trial.
Title of the study (Brief title)	The effects of sensory level neuromuscular electrical stimulation in patients after Total knee arthroplasty
Region	Japan

Condition
Condition	Total knee arthroplasty
Classification by specialty	Surgery in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this early-phase, pilot quasi randomized clinical trial is to investigate the feasibility and possible effects of sensory level neuromuscular electrical stimulation in patients after total knee arthroplasty surgery during inpatient rehabilitation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	maximum voluntary isometric knee extension force
Key secondary outcomes	Lower Muscle Mass, Timed Up and Go test, 2min walk test, Stair Climbing test,Visual Analog Scale, Japanese Knee Osteoarthritis Measure

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	sensory level neuromuscular electrical stimulation(45 minutes per day, 5 days a week, for 3 weeks) and traditional exercise(40 minutes per day, 6 days a week, for 3 weeks)
Interventions/Control_2	traditional exercise(40 minutes per day, 6 days a week, for 3 weeks)
Interventions/Control_3	motor level neuromuscular electrical stimulation(30 minutes per day, 5 days a week, for 3 weeks) and traditional exercise(40 minutes per day, 6 days a week, for 3 weeks)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	underwent a primary unilateral Total knee arthroplasty.
Key exclusion criteria	Contraindications for electrical stimulation(e.g., a pacemaker,severe sensory deficits), bone and joint desease, neurological disorders with motor paralysis, dementia, inability to give informed consent form.
Target sample size	66

Research contact person
Name of lead principal investigator	Yoshida Yosuke
Organization	YamatoKashihara Hospital
Division name	Department of Rehabilitation Medicine
Address	81, Isikawa-cho, Kashihara-shi, Nara
TEL	0744-27-1071
Email	fortunatefield@yahoo.co.jp

Public contact
Name of contact person	Yoshida Yosuke
Organization	YamatoKashihara Hospital
Division name	Department of Rehabilitation Medicine
Address	81, Isikawa-cho, Kashihara-shi, Nara
TEL	0744-27-1071
Homepage URL
Email	fortunatefield@yahoo.co.jp

Sponsor
Institute	YamatoKashihara Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	No outside funding was utilized in this trial.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kio University
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	2013 Year 09 Month 27 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 01 Month 10 Day
Anticipated trial start date	2013 Year 01 Month 10 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 27 Day
Last modified on	2016 Year 04 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000013890