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The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis

Primary Purpose

Postural Kyphosis, Balance

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
The Group I Postural Exercise
The Group II Three-dimensional Exercise Therapy Program
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postural Kyphosis focused on measuring Postural Kyphosis, Exercises, Balance, Respiratory Functions

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Istanbul Medipol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

The Group I

The Group II

Arm Description

The Group I Postural exercise will receive postural exercise for 60 min/day 2 times/week for 8 weeks.

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.

Outcomes

Primary Outcome Measures

Angle of thoracic kyphosis
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.

Secondary Outcome Measures

Balance Assessment (postural stability test)
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
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
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
To asses trunk flexibility, the body will be used for measurement of hyperextension and lateral flexion.
Measurement of pulmonary function
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
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
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.

Full Information

First Posted
September 4, 2018
Last Updated
February 14, 2020
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03706495
Brief Title
The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis
Official Title
The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
August 6, 2019 (Actual)
Study Completion Date
December 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Participants will be randomly allocate 40 participants with kyphosis to two groups; Group I (n=20), Group II (n=20). The Group I, will receive postural exercise for 60 min/day 2 times/week for 8 weeks, while the Group II receive Schroth three-dimensional exercise therapy program for 60 min/day 2 times/week for 8 weeks. Assessment procedure will be held at the beginning and 9th week of study. All subjects will be assessed by each angle of thoracic kyphosis, forward head and forward shoulder angles were measured by using the lateral photographic method, trunk flexibility (lateral and hyperextension), balance (BİODEX balance system) , respiratory function test (measurement of pulmonary function and respiratory muscle strength) , Quality of life SRS-22 and Numeric Rating Scale for pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Kyphosis, Balance
Keywords
Postural Kyphosis, Exercises, Balance, Respiratory Functions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized double-blind
Masking
ParticipantInvestigator
Masking Description
Participants involved in the study and the physiotherapist doing the assessment do not know which exercise group they will be involved in.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Group I
Arm Type
Experimental
Arm Description
The Group I Postural exercise will receive postural exercise for 60 min/day 2 times/week for 8 weeks.
Arm Title
The Group II
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Group I Postural Exercise
Other Intervention Name(s)
The Group I Postural Exercise Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Group II Three-dimensional Exercise Therapy Program
Other Intervention Name(s)
The Group II Schroth Exercise Therapy Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Angle of thoracic kyphosis
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Balance Assessment (postural stability test)
Description
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.
Time Frame
Baseline and 9 weeks
Title
Numeric Rating Scale for Pain
Description
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.
Time Frame
Baseline and 9 weeks
Title
Forward head and forward shoulder angles
Description
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.
Time Frame
Baseline and 9 weeks
Title
Trunk Flexibility Assesment
Description
To asses trunk flexibility, the body will be used for measurement of hyperextension and lateral flexion.
Time Frame
Baseline and 9 weeks
Title
Measurement of pulmonary function
Description
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.
Time Frame
Baseline and 9 weeks
Title
Measurement of respiratory muscle strength
Description
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).
Time Frame
Baseline and 9 weeks
Title
Quality of Life Questionnaire
Description
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.
Time Frame
Baseline and 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candan Algun
Organizational Affiliation
Medipol University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Medipol University
City
Istanbul
State/Province
Beykoz
ZIP/Postal Code
34810
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23948845
Citation
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.
Results Reference
background
PubMed Identifier
28610442
Citation
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.
Results Reference
background
PubMed Identifier
27785478
Citation
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.
Results Reference
background
PubMed Identifier
29097952
Citation
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.
Results Reference
background
PubMed Identifier
16055882
Citation
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.
Results Reference
background

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The Effect of Functional Exercises on Balance With Postural Thoracic Kyphosis

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