UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038433
Receipt number R000043793
Scientific Title The effectiveness of a corrective exercises program with bracing on improving postural hyperkyphosis among adolescents: A randomized controlled clinical trials
Date of disclosure of the study information 2019/10/30
Last modified on 2021/04/12 20:43:17

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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 or person

Institute

University of Hormozgan

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name