- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03706495
The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis
In a normal spine, the sagittal plane has four curvatures that balance each other. The cervical and lumbar spine is lordotic, the thoracic spine and sacral region are kyphotic. In the sagittal plane, there is an average of 40 kyphosis angles between the T1 vertebrae upper end plate and the T12 vertebra lower end plate. Thoracic kyphosis is defined as an increase in the normal thoracic curvature (above 40) of the spine. Postural kyphosis usually occurs when individuals with weak muscle strength exert excessive external loads on their vertebrae. In rapidly growing young people, the abnormal flexion of the spine prevents the development of internal organs and excess thoracic kyphosis causes changes in respiratory functions, as well as postural disorders negatively affect the standing balance. In addition, the posture and appearance of young people with postural kyphosis are affected, which can affect their physical and psychological health.The incidence of hyper-kyphosis abnormality was reported to be 15.3% in 11 year-old children, 38% in 20 to 50 years old adults and 35% in 20 to 64 years old adults. This abnormality is managed by various methods including manual therapy, postural retraining, taping, orthoses and corrective exercises.
When a literature review was conducted, it was observed that no balance evaluation was performed in individuals between 18 and 25 years of age who had postural kyphosis. Therefore, the aim of this study was to investigate the effect of Schroth-based functional exercise and postural exercise on balance, respiratory functions and thoracic angle, who has with postural kyphosis and 18-25 years of age.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beykoz
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Istanbul, Beykoz, Turkey, 34810
- Istanbul Medipol University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged between 18 and 25 years,
- Thoracic kyphosis angle ≥ 40,
- Not being treated for kyphosis within the last six months.
Exclusion Criteria:
- Who has mental problem,
- Spinal fractures and / or operative stories,
- Shoulder joint injury,
- Participants who can not come to the exercise program.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: The Group I
The Group I Postural exercise will receive postural exercise for 60 min/day 2 times/week for 8 weeks.
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Spine anatomy and daily life activities will be informed about proper posture.
Strengthening of postural muscles, stretching (Pectoral Region, M. Psoas Major) and breathing exercise will be performed under the supervision of a physiotherapist.
The Group I will receive postural exercise for 60 min/day 2 times/week for 8 weeks.
Other Names:
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EXPERIMENTAL: The Group II
The Schroth method three-dimensional exercise therapy program consists of individual exercise programs combined with correction patterns.
It is based on sensorimotor and kinesthetic principles.
Goals of this exercise are to facilitate the correction of the asymmetric posture and to maintain the correct posture in the daily activities of the patient.
The Group II receive Schroth method based on three-dimensional exercise therapy program for 60 min/day 2 times/week for 8 weeks.
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The Group II Schroth method corrects the kyphotic posture, with the help of proprioceptive and exteroceptive stimulation and mirror control in the sagittal plane, using specific corrective breathing patterns.
The Schroth method three-dimensional exercise therapy program adapted for the specific posture will be exercised in four specific positions (sitting, supine, standing, prone) under the supervision of a physiotherapist.
Exercise include, trunk elongation, symmetrical sagittal straightening, shoulder traction, corrective breathing and muscle activation by increasing tension (isometric tension).
The Group II will receive Schroth's three-dimensional exercise therapy program for 60 min/day 2 times/week for 8 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Angle of thoracic kyphosis
Time Frame: Baseline
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Spinal alignment was evaluated using a Spinal Mouse (ValedoShape-Hocoma), a computer-assisted noninvasive device.
The method has no medical risk or danger.
The spinal processes of the vertebra from C7 to S3 were marked.
The Spinal Mouse device was slid along the spine from top to bottom to complete the measurement.
The evaluation was administered while the subjects were standing in upright position.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Balance Assessment (postural stability test)
Time Frame: Baseline and 9 weeks
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BIODEX balance systems use any of four test protocols including fall risk, athletic single leg stability, limits of stability and postural stability.
With the Biodex Balance System, the balance of all participants will be evaluated by postural stability test.
The Postural Stability test emphasizes a patient's ability to maintain a center of balance.
The patient's score, or "Stability Index", on this test assesses deviations from center, thus a lower score is more desirable than a higher score.
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Baseline and 9 weeks
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Numeric Rating Scale for Pain
Time Frame: Baseline and 9 weeks
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The Numeric Rating Scale (NRS) for pain is a unidimensional measure of pain intensity in adults.
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain.
The common format is a horizontal bar or line.
The pain NRS is a single 11-point numeric scale, an 11-point numeric scale (NRS 11) with 0 representing one pain extreme ("no pain") and 10 representing the other pain extreme ("pain as bad as you can imagine" and "worst pain imaginable").The NRS will be used for pain assessment of the thoracic region.
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Baseline and 9 weeks
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Forward head and forward shoulder angles
Time Frame: Baseline and 9 weeks
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The lateral photogrammetric measurement method was used to measure the angle of the head protrusion in the tragus-C7 and the proximal C7-acromion in the shoulders.
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Baseline and 9 weeks
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Trunk Flexibility Assesment
Time Frame: Baseline and 9 weeks
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To asses trunk flexibility, the body will be used for measurement of hyperextension and lateral flexion.
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Baseline and 9 weeks
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Measurement of pulmonary function
Time Frame: Baseline and 9 weeks
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The desktop spirometer (Cosmed-Pony FX®) is a hand-held instrument for assessment, will be used for pulmonary function test including forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and ratio of FEV1/FVC.
Pulmonary function will test following the guidelines recommended by the American Thoracic Society (ATS).Participant, sitting in an upright position comfortably on a chair with nose clip attached and head slightly elevated.
They will perform each test for three trials.
The best value of each parameter will record.
The values express as both an absolute value in liters and a percentage of the predicted normal value.
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Baseline and 9 weeks
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Measurement of respiratory muscle strength
Time Frame: Baseline and 9 weeks
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The desktop spirometer (Cosmed-Pony FX®) is a hand-held instrument for assessment respiratory muscles strength both inspiratory and expiratory muscles.
Inspiratory and expiratory muscles strength is expressed in term of Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP), respectively.
MIP and MEP are readily and digitally monitored in units of cmH2O ( pressure range ± 200 cmH2O).
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Baseline and 9 weeks
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Quality of Life Questionnaire
Time Frame: Baseline and 9 weeks
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The Scoliosis Research Society-22 (SRS-22) questionnaire will be used to assess the quality of life.
Turkish validity and reliability studies were conducted.
It consists of 22 questions with five subgroups.
These subgroups are; pain, image / appearance, function / activity, mental health and treatment satisfaction.
For each question, 1 (worst) and 5 (best) were defined as points.
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Baseline and 9 weeks
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Collaborators and Investigators
Investigators
- Study Director: Candan Algun, Medipol University
Publications and helpful links
General Publications
- Seidi F, Rajabi R, Ebrahimi I, Alizadeh MH, Minoonejad H. The efficiency of corrective exercise interventions on thoracic hyper-kyphosis angle. J Back Musculoskelet Rehabil. 2014;27(1):7-16. doi: 10.3233/BMR-130411.
- Feng Q, Wang M, Zhang Y, Zhou Y. The effect of a corrective functional exercise program on postural thoracic kyphosis in teenagers: a randomized controlled trial. Clin Rehabil. 2018 Jan;32(1):48-56. doi: 10.1177/0269215517714591. Epub 2017 Jun 14.
- Berdishevsky H. Outcome of intensive outpatient rehabilitation and bracing in an adult patient with Scheuermann's disease evaluated by radiologic imaging-a case report. Scoliosis Spinal Disord. 2016 Oct 14;11(Suppl 2):40. doi: 10.1186/s13013-016-0094-7. eCollection 2016.
- Singla D, Veqar Z. Association Between Forward Head, Rounded Shoulders, and Increased Thoracic Kyphosis: A Review of the Literature. J Chiropr Med. 2017 Sep;16(3):220-229. doi: 10.1016/j.jcm.2017.03.004. Epub 2017 Sep 28.
- Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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