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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000025641
Receipt No. 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

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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
Email 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
Email mogawa@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029503

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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