UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficasy of neuromuscle stimulation after anterior cruciate ligament reconstruction
Title of the study (Brief title)	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	Munehiro Ogawa
Organization	Nara Medical University
Division name	Department of Orthopaedic Surgery
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	Munehiro Ogawa
Organization	Nara Medical University
Division name	Department of Orthopaedic Surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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