UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015777 |
|---|---|
| Receipt number | R000018362 |
| Scientific Title | Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema |
| Date of disclosure of the study information | 2015/01/05 |
| Last modified on | 2017/06/02 17:22:51 |
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Basic information
Public title
Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema
Acronym
Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema
Scientific Title
Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema
Scientific Title:Acronym
Patient Evaluation List and Assessment of Combined Physical Therapy for Revision of Treatment Guideline of Primary Lymphedema
Region
| Japan |
Condition
Condition
primary lymphedema
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess combined physical therapy for primary lymphedema and revise its treatment guideline
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of volume of lower extremity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
group intensive combined physical therapy
Interventions/Control_2
group maintenance combined physical therapy
Interventions/Control_3
group of reinforcement of compression therapy
3 times a week, 2weeks
Interventions/Control_4
group of reinforcement of lymph-drainage therapy
3 times a week, 2weeks
Interventions/Control_5
group of reinforcement of kinesi therapy
3 times a week, 2weeks
Interventions/Control_6
standard therapy
every day, 2 weeks
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. primary secondary lymphedema of unilateral leg
2. patient without intensive combined physical therapy within three months
3. more than 20 years
Key exclusion criteria
1. edema due to other causes
2. edema of upper extremities or body
3. stage 0-lymphedema
cancer patient
4. expected life time less than one years
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kitagawa |
Organization
Tokushima University Hospital
Division name
Cardiovascular surgery
Zip code
Address
2-50-1, Kuramotocho, Tokushima-City, Tokushima, 770-8503,Japan
TEL
088-633-7581
kitagawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuya Kitagawa |
Organization
Tokushima University Hospital
Division name
Cardiovascular surgery
Zip code
Address
2-50-1, Kuramotocho, Tokushima-City, Tokushima, 770-8503,Japan
TEL
088-633-7581
Homepage URL
kitagawa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
| 2015 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | 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
| 2014 | Year | 11 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018362
