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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020638
Receipt No. R000023529
Scientific Title Effect of muscle strength training using electrical stimulation on postoperative patients
Date of disclosure of the study information 2016/01/20
Last modified on 2016/01/25

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Basic information
Public title Effect of muscle strength training using electrical stimulation on postoperative patients
Acronym Effect of muscle strength training using electrical stimulation on postoperative patients
Scientific Title Effect of muscle strength training using electrical stimulation on postoperative patients
Scientific Title:Acronym Effect of muscle strength training using electrical stimulation on postoperative patients
Region
Japan

Condition
Condition Osteoarthritis, Liver failure
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Postoperative physical therapy was recommended. Among surgery, rotational acetabular osteotomy or liver transplantation induced muscle weakness, and required effective physical therapy.
Electrical stimulation could be effective for muscle strength training. Thus, the aim of this study is to investigate effect of muscle strength training using electrical stimulation on postoperative patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Knee extensor muscle strength is measured using a digital hand-held dynamometer.
Measurement is performed preoperative, and postoperative every 14-days until hospital discharged.
Key secondary outcomes Gait speed is measured. Measurement is performed preoperative, and postoperative every 14-days until hospital discharged.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Muscle strength training with electrical stimulation is performed for 60-min each day, 6-days per week, from postoperative day 1 to hospital discharge.
Interventions/Control_2 Muscle strength training without electrical stimulation is performed for 60-min each day, 6-days per week, from postoperative day 1 to hospital discharge.
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients underwent with rotational acetabular osteotomy or liver transplantation in our single hospital.

Patients agreeed to join this research.
Key exclusion criteria Patients were diagnosed with cognitive impairment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Hayashi
Organization Nagoya Univversity Hospital
Division name Department of Rehabilitation
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Email hayashi.k@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Inoue
Organization Nagoya Univversity Hospital
Division name Department of Rehabilitation
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-741-2111
Homepage URL
Email takagoingmyway@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Univversity Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 20 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 Preinitiation
Date of protocol fixation
2016 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 20 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
2016 Year 01 Month 19 Day
Last modified on
2016 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023529

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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