NCT03706495

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2019

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1 year

First QC Date

September 4, 2018

Last Update Submit

November 8, 2023

Conditions

Keywords

Postural KyphosisExercisesBalanceRespiratory Functions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (7)

  • Balance Assessment (postural stability test)

    Baseline and 9 weeks

  • Numeric Rating Scale for Pain

    Baseline and 9 weeks

  • Forward head and forward shoulder angles

    Baseline and 9 weeks

  • Trunk Flexibility Assesment

    Baseline and 9 weeks

  • Measurement of pulmonary function

    Baseline and 9 weeks

  • +2 more secondary outcomes

Study Arms (2)

The Group I

EXPERIMENTAL

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

The Group II

EXPERIMENTAL

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

Interventions

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.

Also known as: The Group I Postural Exercise Program
The Group I

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.

Also known as: The Group II Schroth Exercise Therapy Program
The Group II

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 25 years,
  • Thoracic kyphosis angle ≥ 40,
  • Not being treated for kyphosis within the last six months.

You may not qualify if:

  • Who has mental problem,
  • Spinal fractures and / or operative stories,
  • Shoulder joint injury,
  • Participants who can not come to the exercise program.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 23948845BACKGROUND
  • 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.

    PMID: 28610442BACKGROUND
  • 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.

    PMID: 27785478BACKGROUND
  • 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.

    PMID: 29097952BACKGROUND
  • 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.

    PMID: 16055882BACKGROUND
  • Ozdemir Gorgu S, Algun ZC. A randomized controlled study of the effect of functional exercises on postural kyphosis: Schroth-based three-dimensional exercises versus postural corrective exercises. Disabil Rehabil. 2023 Jun;45(12):1992-2002. doi: 10.1080/09638288.2022.2083244. Epub 2022 Jun 12.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Candan Algun

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Participants involved in the study and the physiotherapist doing the assessment do not know which exercise group they will be involved in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized double-blind
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof.

Study Record Dates

First Submitted

September 4, 2018

First Posted

October 16, 2018

Study Start

August 1, 2018

Primary Completion

August 6, 2019

Study Completion

December 6, 2019

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations