UMIN-CTR Clinical Trial

Basic information
Public title	Corrective exercises program with bracing for improving postural hyperkyphosis among adolescents
Acronym	Exercises, Bracing and hyperkyphosis
Scientific Title	The effectiveness of a corrective exercises program with bracing on improving postural hyperkyphosis among adolescents: A randomized controlled clinical trials
Scientific Title:Acronym	The effectiveness of a corrective exercises program with bracing on improving postural hyperkyphosis among adolescents: A randomized controlled clinical trials
Region	Asia(except Japan)

Condition
Condition	Postural hyperkyphosis
Classification by specialty	Rehabilitation medicine Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the effects of a corrective exercise program and bracing with only bracing on improving thoracic hyperkyphosis in adolescents with hyperkyphosis.
Basic objectives2	Others
Basic objectives -Others	Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hyperkyphosis angle
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Corrective exercises plus bracing
Interventions/Control_2	Bracing
Interventions/Control_3	Control: Daily activities
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	11 years-old <=
Age-upper limit	16 years-old >=
Gender	Male and Female
Key inclusion criteria	Age range 11-16 years, kyphosis angle 45 degrees, or higher (measured with radiography and the cobb method).
Key exclusion criteria	Have physical activity and sports in addition to corrective programs that affect the outcomes of the research, have any visible malalignment in the pelvis and lower extremities, have congenital or Scheuermann kyphosis, have a history of fracture, surgery, or joint diseases in the spine, shoulder and pelvis, and have a rotation higher than 5 degrees on the forward bending test because of scoliosis
Target sample size	180

Research contact person
Name of lead principal investigator	1st name Mehdi Middle name Last name Gheitasi
Organization	Shahid Beheshti University
Division name	Faculty of Sport Science & Health
Zip code	19839 69411
Address	Faculty of Sport Science & Health, Shahid Beheshti University, Velenjak, Daneshjoo Blvd., Tehran, Iran
TEL	+989123547613
Email	m_gheitasi@sbu.ac.ir

Public contact
Name of contact person	1st name Mohammad Middle name Last name Bayattork
Organization	University of Hormozgan
Division name	Faculty of Humanities Science
Zip code	7916193145
Address	Faculty of Humanities Science, University of Hormozgan, Bandar Abbas, Iran
TEL	+989155521005
Homepage URL
Email	mohammadbayat82@gmail.com

Sponsor
Institute	University of Hormozgan
Institute
Department

Funding Source
Organization	Self funding
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	Shahid Beheshti University
Address	Shahid Beheshti University, Velenjak, Daneshjoo Blvd., Tehran, Iran
Tel	021 29901
Email	m_gheitasi@sbu.ac.ir

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	2019 Year 10 Month 30 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	180
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	2014 Year 01 Month 30 Day
Date of IRB	2019 Year 11 Month 15 Day
Anticipated trial start date	2019 Year 11 Month 15 Day
Last follow-up date	2020 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete	2021 Year 01 Month 01 Day
Date analysis concluded	2021 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2019 Year 10 Month 30 Day
Last modified on	2021 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043793