UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031278 |
|---|---|
| Receipt number | R000035697 |
| Scientific Title | Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty. |
| Date of disclosure of the study information | 2018/03/01 |
| Last modified on | 2018/02/13 17:26:54 |
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Basic information
Public title
Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty.
Acronym
Effect of early NMES on quadriceps muscle after TKA
Scientific Title
Effect of early neuromuscular electrical stimulation on quadriceps muscle after total knee Arthroplasty.
Scientific Title:Acronym
Effect of early NMES on quadriceps muscle after TKA
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effect of neuromuscular electrical stimulation on the quadriceps muscle performed from 2 days after total replacement surgery until 2 weeks after total knee replacement surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Quadriceps muscle strength
Key secondary outcomes
Resting pain, quadriceps maximal contraction pain, knee flexion movement range, knee joint extension range, quadriceps muscle cross sectional area (and IMAT), patellar upper extreme level circumference, patellar superior proximal level circumference Diameter, TUG, SCT
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
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Neuromuscular electrical stimulation to the quadriceps femoris(Ten times in total for 30 minutes, between 2 days and 14 days after surgery)
Interventions/Control_2
Non-intervention
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
| 60 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo total knee arthroplasty for osteoarthritis
Key exclusion criteria
patients with bilateral TKA, patients with orthopedic disease with strong pain on the other side, patients with infection, neurological symptoms (paralysis of lower limbs etc.) Patients with dementia, skin hyperresponsiveness or skin trouble
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Hisano |
Organization
Shiraniwa hospital
Division name
Department of Rehabilitation
Zip code
Address
6-10-1, Shiraniwadai, Ikoma-shi, Nara, 630-0136, Japan
TEL
0743-70-0022
takashi807@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Hisano |
Organization
Elixir
Division name
Nursing home care
Zip code
Address
4137, Kamimachi, Ikoma-shi, Nara, 630-0131, Japan
TEL
0743-70-0070
Homepage URL
takashi807@gmail.com
Sponsor or person
Institute
Department of Rehabilitation Shiraniwa hospital
Institute
Department
Personal name
Funding Source
Organization
Shiraniwa hospital
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
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
医療法人社団松下会 白庭病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 13 | Day |
Last modified on
| 2018 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035697
