Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000565640
Ethics application status
Approved
Date submitted
11/04/2023
Date registered
25/05/2023
Date last updated
25/05/2023
Date data sharing statement initially provided
25/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pain, physical activity, posture and quality of life in post-COVID-19 individuals with idiopathic scoliosis
Scientific title
Pain, physical activity, posture and quality of life in individuals with idiopathic scoliosis who have had COVID-19
Secondary ID [1] 309410 0
Nil known
Universal Trial Number (UTN)
U1111-1291-0986
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 329646 0
Postural disorder 329649 0
Physical inactivity 329651 0
COVID-19 329655 0
Poor quality of life 329657 0
Idiopathic scoliosis 329659 0
Condition category
Condition code
Musculoskeletal 326566 326566 0 0
Other muscular and skeletal disorders
Infection 326587 326587 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In this study, the data will be collected face-to-face from all individuals; scoliosis degree measurement, number of steps, pain, posture and quality of life will be evaluated in these post-COVID-19 individuals with idiopathic scoliosis, by comparing them with scoliosis individuals who have not had COVID-19. The data to be obtained from all these evaluations will be collected from the individuals at one time and over a period of approximately 1 hour at the most. Step count tracking with pedometer will be done for each individual for 3 days.
Intervention code [1] 325844 0
Not applicable
Comparator / control treatment
The control group will consist of individuals with idiopathic scoliosis without COVID-19.
Control group
Active

Outcomes
Primary outcome [1] 334411 0
Daily average step counts will be recorded via pedometers.
Timepoint [1] 334411 0
at survey time, everyday within 3 days after confirming enrolment
Secondary outcome [1] 420562 0
Pain severity will be evaluated via the Numerical Rating Scale (SDS).
Timepoint [1] 420562 0
at survey time
Secondary outcome [2] 420563 0
The status of quality of life will be evaluated using Scoliosis Research Society-22 (SRS-22) questionnaire.
Timepoint [2] 420563 0
at survey time
Secondary outcome [3] 420564 0
Posture deviations will be determined according to the deviation scores in the joint centers obtained by photographing the posture of the individuals and uploading them to the system. Posture assessment will be made with a mobile application based on the concept of postural analysis with artificial intelligence.
Timepoint [3] 420564 0
At survey time
Secondary outcome [4] 420568 0
Degree of vertebtral rotation will be evaluated through a scoliometer.
Timepoint [4] 420568 0
at survey time
Secondary outcome [5] 420645 0
Pain severity will be assessed via Pressure Algometry
Timepoint [5] 420645 0
at survey time

Eligibility
Key inclusion criteria
Inclusion criteria for individuals with idiopathic scoliosis who have experienced COVID-19;
• being 18 years of age or older
* Volunteering to participate in the study
* Having been diagnosed with idiopathic scoliosis
• Being able to walk independently
• Having been diagnosed with COVID-19 and having recovered and been discharged.

Inclusion criteria for individuals with idiopathic scoliosis who have not had COVID-19;
• being 18 years of age or older
* Volunteering to participate in the study
* Being diagnosed with idiopathic scoliosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for individuals with idiopathic scoliosis who have had COVID-19;
• Having been diagnosed with COVID-19 in the last 15 days
• Being suspected of COVID-19
• Having mental problems that may affect cooperation
• Having an acute or chronic infection that may affect the evaluations to be made within the scope of the study.
• Participating in any professional sports activity
• Having any surgery to prevent walking, having a chronic disease, orthopedic/neurological/cardiopulmonary disease, physical or mental disability and/or cognitive impairment
• Using analgesics and other interactive drugs that will affect assessments
•Being pregnant

Exclusion criteria for individuals with idiopathic scoliosis who have not had COVID-19;
• Having had at least one COVID-19
• Being suspected of COVID-19
• Having any mental or physical disability
• Having any acute or chronic illness
• Having analgesic drug use that will affect the evaluations
. Being pregnant

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size required for the study was calculated using the GPower program. It was determined that at least 25 individuals should be included in each of the groups with and without COVID-19 in order to determine the mean difference in the number of steps (2,831 steps/day) between the two group and to reach an a value of 0.05, an effect size of 0.95, and a power of 95%. Statistical analyzes will be made using SPSS 15.0 program. By using visual (histogram and probability graphs) and analytical methods (Kolmogorov-Smirnov/Shapiro-Wilk tests), the conformity of all variables to normal distribution will be investigated. Descriptive analyzes will be given using numbers and percentage (%) for categorical variables, median and interquartile range (IQR) for non-normally distributed variables, mean and standard deviation (x±ss) for normally distributed variables. The Independent Sample t test (Student t test) will be used to compare the variables that fit the normal distribution, the Mann-Whitney U test will be used to compare the data that do not fit, and the Chi-square test will be used to compare the uncountable data. While investigating the relationships between parameters, Pearson test will be used for normally distributed variables and Spearman test will be used for non-normally distributed variables. The probability of error in statistical analysis will be determined as p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25386 0
Turkey
State/province [1] 25386 0
izmir

Funding & Sponsors
Funding source category [1] 313605 0
Self funded/Unfunded
Name [1] 313605 0
None
Country [1] 313605 0
Primary sponsor type
Individual
Name
GÜLSAH BARGI
Address
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country
Turkey
Secondary sponsor category [1] 315395 0
Individual
Name [1] 315395 0
Merve Nur Yüksel
Address [1] 315395 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country [1] 315395 0
Turkey
Secondary sponsor category [2] 315397 0
Individual
Name [2] 315397 0
Ali Ertugrul
Address [2] 315397 0
Balikesir Atatürk City Hospital, Gaziosmanpasa, 209. Sk. No:26, 10100 Altieylül/Balikesir
Country [2] 315397 0
Turkey
Secondary sponsor category [3] 315399 0
Individual
Name [3] 315399 0
Rukiye Yazici
Address [3] 315399 0
Atatürk, Balikesir State Hospital, Acil Servis Iç Yolu 1-10, 10020 Karesi/Balikesir
Country [3] 315399 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312781 0
Izmir Democracy University Non-Interventional Clinical Research of the Ethics Committee
Ethics committee address [1] 312781 0
Ethics committee country [1] 312781 0
Turkey
Date submitted for ethics approval [1] 312781 0
Approval date [1] 312781 0
04/01/2023
Ethics approval number [1] 312781 0
2023/01-10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125894 0
A/Prof GÜLSAH BARGI
Address 125894 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 125894 0
Turkey
Phone 125894 0
+905317938766
Fax 125894 0
+90 232 260 1004
Email 125894 0
[email protected]
Contact person for public queries
Name 125895 0
GÜLSAH BARGI
Address 125895 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 125895 0
Turkey
Phone 125895 0
+905317938766
Fax 125895 0
+90 232 260 1004
Email 125895 0
[email protected]
Contact person for scientific queries
Name 125896 0
GÜLSAH BARGI
Address 125896 0
Izmir Democracy University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Mehmet Ali Akman Quarter, 13th street, No. 2, 35140 Güzelyali, Konak, Izmir, Turkey.
Country 125896 0
Turkey
Phone 125896 0
+905317938766
Fax 125896 0
+90 232 260 1004
Email 125896 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I can not share the data of individuals included in the study in our country within the scope of the personal data protection law.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.