UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018494 |
|---|---|
| Receipt number | R000021405 |
| Scientific Title | Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2015/07/30 17:13:26 |
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Basic information
Public title
Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction
Acronym
Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction
Scientific Title
Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction
Scientific Title:Acronym
Effects of postoperative neuromuscular erectrical stimulation on quadriceps strength in ACL reconstruction
Region
| Japan |
Condition
Condition
rupture of anterior cruciate ligament
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To certificate that neuromuscular electrical stimulation improve recovery of quadriceps muscle strength in patients undergoing ACL reconstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of muscle strength in 3,5months afeter operation
Key secondary outcomes
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
Beginning on the third or fourth day postoperatively,the stimulater is used for 20 minute session per day, over than 3 days per week.
In 2 weeks after operation, it is used over than 2 days per week,to 5months after operation.
Interventions/Control_2
regular treatment, rehabilitation
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients between the ages of 18 and 40 years
Can get exercise over than 3times per week
Can come to hospital for rehabilitation over than 2 times after leaving hospital
Key exclusion criteria
Inflammatory arthritis ,implanted pacemakers or defibrillators,dermatological conditions of thigh
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saito Yoshihiko |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Orthopaedics
Zip code
Address
5-9-1 Shirokane,MInato-ku,Tokyo 108-8642
TEL
03-3444-6161
saito-y@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saito Yoshihiko |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Orthopaedics
Zip code
Address
5-9-1 Shirokane,MInato-ku,Tokyo 108-8642
TEL
03-3444-6161
Homepage URL
saito-y@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
SHILAC JAPAN
Organization
Division
Category of Funding Organization
Profit 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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 08 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 10 | 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
| 2015 | Year | 07 | Month | 30 | Day |
Last modified on
| 2015 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021405
