UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019558 |
|---|---|
| Receipt number | R000022522 |
| Scientific Title | A Study on Usefulness of exercise with vascular occlusion and whole body vibration for patients after anterior cruciate ligament recomstruction |
| Date of disclosure of the study information | 2015/10/29 |
| Last modified on | 2018/05/01 12:59:43 |
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Basic information
Public title
A Study on Usefulness of exercise with vascular occlusion and whole body vibration for patients after anterior cruciate ligament recomstruction
Acronym
Exercise with vascular occlusion and whole body vibration after anterior cruciate ligament recomstruction
Scientific Title
A Study on Usefulness of exercise with vascular occlusion and whole body vibration for patients after anterior cruciate ligament recomstruction
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
tkobayas@ndmc.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuo Kobayashi |
Organization
National Defense Medical College
Division name
Rehabilitation
Zip code
Address
3-2, Namiki, Tokorozawa
TEL
04-2995-1511
Homepage URL
tkobayas@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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)
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
防衛医科大学校
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 29 | 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 | 07 | Month | 24 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022522
