UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of exercises with a pelvic realignment device on low back and pelvic girdle pain after the child delivery: a randomized control study
Title of the study (Brief title)	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	Obsterics 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	Kazuyohi Gamada
Organization	Hiroshima International University
Division name	Graduate School of Medical Technology and Health Welfare Sciences
Address	555-36 kurosegakuendai higashihiroshima hiroshima Japan
TEL	0823-70-4510
Email	kazugamada@ortho-pt.com

Public contact
Name of contact person	Asuka Sakamoto
Organization	Seirei Christopher University
Division name	Department of physical therapy, school of rehabilitation sciences
Address	3453 Mikatahara, Kita-ku Hamamatsu Shizuoka Japan
TEL	053534391998
Homepage URL
Email	asuka-s@seirei.ac.jp

Sponsor
Institute	Hiroshima International University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035379