The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03706495|
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : August 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Postural Kyphosis Balance||Behavioral: The Group I Postural Exercise Behavioral: The Group II Three-dimensional Exercise Therapy Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized double-blind|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Participants involved in the study and the physiotherapist doing the assessment do not know which exercise group they will be involved in.|
|Official Title:||The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis|
|Actual Study Start Date :||August 1, 2018|
|Estimated Primary Completion Date :||August 6, 2019|
|Estimated Study Completion Date :||August 6, 2019|
Experimental: The Group I
The Group I Postural exercise will receive postural exercise for 60 min/day 2 times/week for 8 weeks.
Behavioral: The Group I Postural Exercise
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 Name: The Group I Postural Exercise Program
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.
Behavioral: The Group II Three-dimensional Exercise Therapy Program
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 Name: The Group II Schroth Exercise Therapy Program
- Angle of thoracic kyphosis [ Time Frame: Baseline ]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.
- Balance Assessment (postural stability test) [ Time Frame: Baseline and 9 weeks ]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.
- Numeric Rating Scale for Pain [ Time Frame: Baseline and 9 weeks ]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.
- Forward head and forward shoulder angles [ Time Frame: Baseline and 9 weeks ]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.
- Trunk Flexibility Assesment [ Time Frame: Baseline and 9 weeks ]To asses trunk flexibility, the body will be used for measurement of hyperextension and lateral flexion.
- Measurement of pulmonary function [ Time Frame: Baseline and 9 weeks ]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.
- Measurement of respiratory muscle strength [ Time Frame: Baseline and 9 weeks ]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).
- Quality of Life Questionnaire [ Time Frame: Baseline and 9 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706495
|Contact: Sena Ozdemiremail@example.com|
|Istanbul Medipol University||Recruiting|
|Istanbul, Beykoz, Turkey, 34810|
|Contact: Sena Ozdemir 00905425751229 firstname.lastname@example.org|
|Study Director:||Candan Algun||Istanbul Medipol University|