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
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
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
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
