UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030986 |
|---|---|
| Receipt number | R000035379 |
| Scientific Title | The effects of exercises with a pelvic realignment device on low back and pelvic girdle pain after the child delivery: a randomized control study |
| Date of disclosure of the study information | 2018/01/25 |
| Last modified on | 2018/08/27 21:12:32 |
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Basic information
Public title
The effects of exercises with a pelvic realignment device on low back and pelvic girdle pain after the child delivery: a randomized control study
Acronym
The effects of exercises with a pelvic realignment device: a randomized control study
Scientific Title
The effects of exercises with a pelvic realignment device on low back and pelvic girdle pain after the child delivery: a randomized control study
Scientific Title:Acronym
The effects of exercises with a pelvic realignment device: a randomized control study
Region
| Japan |
Condition
Condition
low back and pelvic girdle pain after child delivery
Classification by specialty
| Obstetrics and Gynecology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine the effects of an PRD-aided exercise program after the delivery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analog scale(VAS), Pelvic girdle questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the exercise program with ReaLine CORE(RLC)(GLAB corp.)
Interventions/Control_2
the exercise program with pelvic stabilized exercise
Interventions/Control_3
no exercise
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
pregnancy
having unmedicated vaginal delivery
healthiness of the child and mother who couldstart to care her new baby from the next day after the delivery
Key exclusion criteria
cesarean section
health problems excepting pelvic girdle pain
difficulty in daily living
communication disorders
mental and physical disabilities
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyohi Gamada |
Organization
Hiroshima International University
Division name
Graduate School of Medical Technology and Health Welfare Sciences
Zip code
Address
555-36 kurosegakuendai higashihiroshima hiroshima Japan
TEL
0823-70-4510
kazugamada@ortho-pt.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Sakamoto |
Organization
Seirei Christopher University
Division name
Department of physical therapy, school of rehabilitation sciences
Zip code
Address
3453 Mikatahara, Kita-ku Hamamatsu Shizuoka Japan
TEL
053534391998
Homepage URL
asuka-s@seirei.ac.jp
Sponsor or person
Institute
Hiroshima International University
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Self funding
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
| 2018 | Year | 01 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035379
