UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025641 |
|---|---|
| Receipt number | R000029503 |
| Scientific Title | Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/01/12 14:33:32 |
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Basic information
Public title
Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction
Acronym
Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction
Scientific Title
Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction
Scientific Title:Acronym
Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction
Region
| Japan |
Condition
Condition
Anterior Cruciate ligament injury
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess the efficacy of neuromuscular electrical stimulation after anterior cruciate ligament reconstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
muscle power
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Neuromuscular Electrical Stimulation
Interventions/Control_2
without Neuromuscular Electrical Stimulation
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
| 13 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients agreed to undergo ACLR and were able to implement our standard postoperative rehabilitation protocol.
Key exclusion criteria
Exclusion criteria included a history of OA or inflammatory arthritis, earlier surgery to either knee for a previous injury, neuromusclar disease, pacemaker,anesthesia,and allergy patient.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Munehiro Ogawa |
Organization
Nara Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
840, Shijyo-cho, Kashihara, Nara, 634-8522 Japan
TEL
0744-22-3051
mogawa@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Munehiro Ogawa |
Organization
Nara Medical University
Division name
Department of Orthopaedic Surgery
Zip code
Address
840, Shijyo-cho, Kashihara, Nara, 634-8522 Japan
TEL
0744-22-3051
Homepage URL
mogawa@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 04 | 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
| 2017 | Year | 01 | Month | 12 | Day |
Last modified on
| 2017 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029503
