UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020638 |
|---|---|
| Receipt number | 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 23:22:03 |
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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
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
takagoingmyway@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Univversity Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023529
