UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Study on Usefulness of exercise with vascular occlusion and whole body vibration for patients after anterior cruciate ligament recomstruction
Title of the study (Brief title)	Exercise with vascular occlusion and whole body vibration after anterior cruciate ligament recomstruction
Region	Japan

Condition
Condition	Rupture of the anterior cruciate ligament
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate whether both exercise with vascular occlusion and whole body vibration results in better performance than only exercise with vascular occlusion after anterior cruciate ligament reconstruction or not.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluate the followings one year after operation. Results of performance test Strength of the quadriceps femoris Ratio of mscle tissues in the whole body weight
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Patients performed rehabilitation using vascular occlusion only after anterior cruciate ligament reconstruction
Interventions/Control_2	Patients performed rehabilitation using vascular occlusion with whole body vibration after anterior cruciate ligament reconstruction
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	16 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	patients performed ACL reconstruction at Natinal Defense Medical College. more than 4 weeks after ACL reconstruction obtained informed consent for research
Key exclusion criteria	sever complication unhealed operation wound after orthopedic surgery using metal implant in several months
Target sample size	50

Research contact person
Name of lead principal investigator	Tatsuo Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Email	tkobayas@ndmc.ac.jp

Public contact
Name of contact person	Tatsuo Kobayashi
Organization	National Defense Medical College
Division name	Rehabilitation
Address	3-2, Namiki, Tokorozawa
TEL	04-2995-1511
Homepage URL
Email	tkobayas@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
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	防衛医科大学校

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 29 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 07 Month 24 Day
Anticipated trial start date	2013 Year 08 Month 01 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	2015 Year 10 Month 29 Day
Last modified on	2018 Year 05 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022522