HyperkyphosisNCT04523597
"Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"
An observational study of Hyperkyphosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of our study; is to investigate how balance parameters are affected in comparison with healthy children in children with thoracic hyperkyphosis and to examine the relationship of these results with muscle strength, shortness-flexibility, pain, range of motion, functional status, physical activity level and… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperkyphosis
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children admitted to the orthopedics and Traumatology Outpatiant Clinic of Istanbul University, Istanbul Faculty of Medicine, and diagnosed with "thoracic Hypercyphosis" as a result of radiography evaluation.
Who may be able to join
- Thoracic kyphosis angle: ≥ 45˚ (Cobb)
- Age between 9-18 years
- Volunteering to participate in the study
- Not physiotherapy
- Not cest tretment
Who cannot join
- Spinal surgery history
- Vision and hearing impairment
- Difficulty in detecting commands given
- Lower extremity affect that may affect balance
- Systemic disorder associated with balance
- Neurological influence
- > 20˚ (Cobb) scoliosis deformity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrapaşa, Faculty of Health Sciences
Istanbul
About this study
The purpose of our study; is to investigate how balance parameters are affected in comparison with healthy children in children with thoracic hyperkyphosis and to examine the relationship of these results with muscle strength, shortness-flexibility, pain, range of motion, functional status, physical activity level and quality of life. The hypothesis of the study is that children with thoracic hyperkyphosis have impaired balance compared to their healthy peers. With this finding, it can be ensured that clinical evaluations and treatment strategies for balance in children with hyperkifosis are included in the treatment plan. 31 children with thoracic hyperkyphosis were included in the evaluation group, and 31 children with normal physiological curves were included in the control group. Participants were evaluated once by the physical therapist.
Read the detailed description
The study was included chidren with hyperkyphosis at the İstanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. G*Power 3.1.9.2 program was used to calculate the sample size. Due to the absence of MCID value for the Biodex Balance System in the literature while sample size calculation, the average values for males and females are 3.83 and 3.05 based on the "Overall Stability Index" based on the dominant side from a similar study conducted with healthy young adults; standard deviation values were placed in the formula as 1.03 and 1.13 (σ). (power=80%, α=0.05, significance level 2-tailed, and effect size d = 0.73). A total of 62 cases were decided to be included in the study, with 31 individuals per group. Participants were evaluated once by the physical therapist. Evaluation consist of demographic information form, Biodex Balance System, visual analog scale, "Hand-held" dynamometer, range of motion, pektoralis minor muscle flexibility, triple-hop distance test, 20-m sprint test, Physical Activity Questionnaire for Children, Pediatric Quality of Life Inventory, functional reach test and occiput-wall distance. SPSS (Statistical Package for Social Sciences) 22 statistical program was used for the statistical analysis of the data. Normality was assessed using the Shapiro-Wilk test. The "Chi-Square Test" was used to compare the difference between groups for categorical variables such as gender, dominant side, and educational status. The statistical analysis for group comparisons was performed using the "Mann-Whitney U Test" for non-parametric samples. Correlation analysis between the data was done with "Spearmann r Test". In all tests, a significance level of 0.05 (5%) was used.
- Conditions
- Hyperkyphosis
- Keywords
- Kyphosis, Postural Stability, Biodex Balance System, Equilibrium
- Medical subject headings
- Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| toracic hyperkyphosis | children with COBB angle ≥ 45˚ | |
| control | children with kyphosis index < 13 measured using the flexicurve ruler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biodex Balance System
Biodex Balance System is a valid instrument used to measure postural stability in static and dynamic conditions. The stability platform allows for varying levels of difficulty of stability testing from level 1 (stabil) to level 12 (least stable). A high score is indicative of a lot of movement and indicates poor balance. In present study was assessed average Overall, AP, and ML stability scores under the following 4 position: right-leg static balance, left-leg static balance, bilateral static balance and bilateral dynamic balance at BBS level 8 (moderately unstable). Each position was applied with eyes open and closed.
Measured: the cases were evaluated once.
Secondary outcomes (10)
Visual Analog Scale
Visual Analogue Scale will be use to assess pain. The scale consists of a horizontal line between 0-100mm. A value of 0 mm indicates "no pain" and a value of 100 mm indicates "the most severe". The severity of the pain that the patients feel in the back and neck regions during rest, activity and at night will be evaluated numerically.
Measured: the cases were evaluated once.
"Hand-held" dynamometer
Maximal isometric contraction was evaluated with "Hand-held" dynamometer (Lafeyette Instrument®, Lafayette, IN) using a standard protocol and recorded in kg / Newton. In our study, strength of trunk flexion and extansion, upper-middle-lower trapesiuz, serratus anterior, latissimus dorsi, bilateral hip flexion, extansion, abduction, knee flexion, extansion and ankle plantarflexion, dorsiflexion were examined bilaterally.
Measured: the cases were evaluated once.
Range of Motion
Goniometric measurement is an objectively used method in the evaluation of ROM in the clinic. In our study, trunk flexion, extansion and lateral flexion were measured with goniometer.
Measured: the cases were evaluated once.
Triple-Hop Distance (THD) test
Triple-Hop Distance test is considered to be a valid and reliable test in evaluating the functional status as it is easy to apply and does not require much time and equipment. Participants performed 3 consecutive maximal hops forward on the right and left limb. It was measured with tape the distance hopped from the starting line to the point where the heel struck the ground upon completing the third hop. The maximum distance achieved during the 3 trials was recorded in centimeters and was used for analysis. High scores indicate that the functional condition is good.
Measured: the cases were evaluated once.
20-m sprint test
20-m sprint test is used to evaluate the maximum running time of the participants. Maximal effort sprint was assessed from a stationary start. Participants was instructed to stand with one foot right behind the starting line and to accelerate at maximum effort to the finish line. The best value of 3 trials (minimal sprint time) with a 2 min rest between trials was used for further data analysis. Time was taken with a stop watch.
Measured: the cases were evaluated once.
Physical Activity Questionnaire for Children
The physical activity level of the participants wasevaluated with the Physical Activity Questionnaire for Children , which is frequently used in the clinic. This questionnaire consists of 9 items in the 5-point Likert type that questions the physical activities performed in the last 7 days and how often these activities are performed. A high score on the scale indicates that the physical activity level is high.
Measured: the cases were evaluated once.
Pediatric Quality of Life Inventory
Pediatric Quality of Life Inventory is a quality-of-life scale with validity and reliability of 23 items, which are frequently used in research to question the quality of life in children and adolescents. The higher the score obtained from the scale, the higher the quality of life increases.
Measured: the cases were evaluated once.
Functional reach test
It measures the distance (using a tape at the level of the acromion) that an participants are able to reach forward and sides from a starting standing position with a fixed base of support without loss of balance. In our study, the distance to the forward and sides of the cases was tested. For each position were made 3 measurements and their average values were calculated. High scores indicate that the functional balance is good.
Measured: the cases were evaluated once.
The occiput-wall distance
The occiput-wall distance is a surrogate measure of kyphosis.The method has been verified for its reliability and validity. Two rulers were used to quantify the outcomes: the first ruler was placed on the landmark (occiput), and the second ruler was used to measure a perpendicular distance from the first ruler (occiput) to the wall. The measurement was repeated for three trials with a period of rest as needed between the trials, and the average distance over the three trials was used for the data analysis. Higher values indicate an increase in kyphosis angle.
Measured: the cases were evaluated once.
muscle flexibility of pektoralis minor
The patients were placed in the supine position with their forearms pronated on the side of the body, in this position the distance between the acromion and the bed was measured with a tape measure and the value was recorded in cm. High values indicate muscle shortness.
Measured: the cases were evaluated once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Feb 2019
- Primary completion30 Jan 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkyphosisStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Elif Nacar, Istanbul University - Cerrahpasa
- Investigators
- Nazlı Nacar, Principal investigator, Istanbul University-Cerrapaşa, Faculty of Health SciencesAyşe Zengin Alpözgen, Study director, Istanbul University-Cerrapaşa, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523597
- Sponsor's protocol ID
- Istanbul University Cerrahpasa
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Evaluation of Static and Dynamic Postural Balance in Children With Thoracic Hyperkyphosis"
- ClinicalTrials.gov ID
- NCT04523597
- Acronym / sponsor ID
- Istanbul University Cerrahpasa
- Conditions
- Hyperkyphosis
- Keywords
- Kyphosis, Postural Stability, Biodex Balance System, Equilibrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 21 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study; is to investigate how balance parameters are affected in comparison with healthy children in children with thoracic hyperkyphosis and to examine the relationship of these results with muscle strength, shortness-flexibility, pain, range of motion, functional status, physical activity level and quality of life. The hypothesis of the study is that children with thoracic hyperkyphosis have impaired balance compared to their healthy peers. With this finding, it can be ensured that clinical evaluations and treatment strategies for balance in children with hyperkifosis are included in the treatment plan. 31 children with thoracic hyperkyphosis were included in the evaluation group, and 31 children with normal physiological curves were included in the control group. Participants were evaluated once by the physical therapist.
Detailed description
The study was included chidren with hyperkyphosis at the İstanbul University-Cerrahpaşa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. G*Power 3.1.9.2 program was used to calculate the sample size. Due to the absence of MCID value for the Biodex Balance System in the literature while sample size calculation, the average values for males and females are 3.83 and 3.05 based on the "Overall Stability Index" based on the dominant side from a similar study conducted with healthy young adults; standard deviation values were placed in the formula as 1.03 and 1.13 (σ). (power=80%, α=0.05, significance level 2-tailed, and effect size d = 0.73). A total of 62 cases were decided to be included in the study, with 31 individuals per group. Participants were evaluated once by the physical therapist. Evaluation consist of demographic information form, Biodex Balance System, visual analog scale, "Hand-held" dynamometer, range of motion, pektoralis minor muscle flexibility, triple-hop distance test, 20-m sprint test, Physical Activity Questionnaire for Children, Pediatric Quality of Life Inventory, functional reach test and occiput-wall distance. SPSS (Statistical Package for Social Sciences) 22 statistical program was used for the statistical analysis of the data. Normality was assessed using the Shapiro-Wilk test. The "Chi-Square Test" was used to compare the difference between groups for categorical variables such as gender, dominant side, and educational status. The statistical analysis for group comparisons was performed using the "Mann-Whitney U Test" for non-parametric samples. Correlation analysis between the data was done with "Spearmann r Test". In all tests, a significance level of 0.05 (5%) was used.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| toracic hyperkyphosis | – | –children with COBB angle ≥ 45˚ |
| control | – | –children with kyphosis index < 13 measured using the flexicurve ruler |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children admitted to the orthopedics and Traumatology Outpatiant Clinic of Istanbul University, Istanbul Faculty of Medicine, and diagnosed with "thoracic Hypercyphosis" as a result of radiography evaluation.
Key inclusion criteria (5 listed)
- Thoracic kyphosis angle: ≥ 45˚ (Cobb)
- Age between 9-18 years
- Volunteering to participate in the study
- Not physiotherapy
- Not cest tretment
Key exclusion criteria (7 listed)
- Spinal surgery history
- Vision and hearing impairment
- Difficulty in detecting commands given
- Lower extremity affect that may affect balance
- Systemic disorder associated with balance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biodex Balance System
Time frame: the cases were evaluated once.
Biodex Balance System is a valid instrument used to measure postural stability in static and dynamic conditions. The stability platform allows for varying levels of difficulty of stability testing from level 1 (stabil) to level 12 (least stable). A high score is indicative of a lot of movement and indicates poor balance. In present study was assessed average Overall, AP, and ML stability scores under the following 4 position: right-leg static balance, left-leg static balance, bilateral static balance and bilateral dynamic balance at BBS level 8 (moderately unstable). Each position was applied with eyes open and closed.
10 secondary outcomes
Visual Analog Scale
Time frame: the cases were evaluated once.
"Hand-held" dynamometer
Time frame: the cases were evaluated once.
Range of Motion
Time frame: the cases were evaluated once.
Triple-Hop Distance (THD) test
Time frame: the cases were evaluated once.
20-m sprint test
Time frame: the cases were evaluated once.
Physical Activity Questionnaire for Children
Time frame: the cases were evaluated once.
Pediatric Quality of Life Inventory
Time frame: the cases were evaluated once.
Functional reach test
Time frame: the cases were evaluated once.
The occiput-wall distance
Time frame: the cases were evaluated once.
muscle flexibility of pektoralis minor
Time frame: the cases were evaluated once.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazlı Nacar principal investigator
Istanbul University-Cerrapaşa, Faculty of Health Sciences
Ayşe Zengin Alpözgen study director
Istanbul University-Cerrapaşa, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkyphosis, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biodex Balance System (time frame: the cases were evaluated once.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.