Pectus Carinatum Clinical Trial
Official title:
Effects of Exercise Therapy in Addition to Compression Orthotics in Patients With Pectus Carinatum
Pectus Carinatum (PC); deformity in which the front wall of the chest protrudes forward. Non-invasive treatment approaches for PC include compression orthosis and exercises that target the deformity itself and concurrent postural impairment and scoliosis. In addition, the formation of muscles can help close the deformity. Although exercise training is recommended, there is no randomized study showing its effectiveness in the literature. Therefore, in our study, the investigators aimed to investigate the effectiveness of exercise therapy in addition to compression orthotics.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | March 15, 2020 |
Est. primary completion date | January 15, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 10 Years to 18 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with PC by doctor and indicated for the first time orthotic use - A correction pressure of less than 10 pounds per square inch in the compression test - 10-18 years old, - Discontented with this deformity Exclusion Criteria: - Previous orthosis use - Severe scoliosis (Cobb angle above 20 degrees) - Having chronic systemic disease - Having serious psychiatric illness - Having complex mixed pectus deformity |
Country | Name | City | State |
---|---|---|---|
Turkey | Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation | Istanbul | Atasehir |
Lead Sponsor | Collaborator |
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Acibadem University |
Turkey,
Akkas Y, Gülay Peri N, Koçer B, Gülbahar G, Baran Aksakal FN. The prevalence of chest wall deformity in Turkish children. Turk J Med Sci. 2018 Dec 12;48(6):1200-1206. doi: 10.3906/sag-1807-180. — View Citation
Bahadir AT, Kuru P, Afacan C, Ermerak NO, Bostanci K, Yuksel M. Validity and reliability of the Turkish version of the nuss questionnaire modified for adults. Korean J Thorac Cardiovasc Surg. 2015 Apr;48(2):112-9. doi: 10.5090/kjtcs.2015.48.2.112. Epub 2015 Apr 5. — View Citation
Banever GT, Konefal SH, Gettens K, Moriarty KP. Nonoperative correction of pectus carinatum with orthotic bracing. J Laparoendosc Adv Surg Tech A. 2006 Apr;16(2):164-7. — View Citation
Canavan PK, Cahalin L. Integrated physical therapy intervention for a person with pectus excavatum and bilateral shoulder pain: a single-case study. Arch Phys Med Rehabil. 2008 Nov;89(11):2195-204. doi: 10.1016/j.apmr.2008.04.014. — View Citation
Ewert F, Syed J, Wagner S, Besendoerfer M, Carbon RT, Schulz-Drost S. Does an external chest wall measurement correlate with a CT-based measurement in patients with chest wall deformities? J Pediatr Surg. 2017 Oct;52(10):1583-1590. doi: 10.1016/j.jpedsurg.2017.04.011. Epub 2017 Apr 27. — View Citation
Haje SA, Bowen JR. Preliminary results of orthotic treatment of pectus deformities in children and adolescents. J Pediatr Orthop. 1992 Nov-Dec;12(6):795-800. — View Citation
Kravarusic D, Dicken BJ, Dewar R, Harder J, Poncet P, Schneider M, Sigalet DL. The Calgary protocol for bracing of pectus carinatum: a preliminary report. J Pediatr Surg. 2006 May;41(5):923-6. — View Citation
Lee RT, Moorman S, Schneider M, Sigalet DL. Bracing is an effective therapy for pectus carinatum: interim results. J Pediatr Surg. 2013 Jan;48(1):184-90. doi: 10.1016/j.jpedsurg.2012.10.037. — View Citation
Martinez-Ferro M, Bellia Munzon G, Fraire C, Abdenur C, Chinni E, Strappa B, Ardigo L. Non-surgical treatment of pectus carinatum with the FMF(®) Dynamic Compressor System. J Vis Surg. 2016 Mar 17;2:57. doi: 10.21037/jovs.2016.02.20. eCollection 2016. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pectus severity index | Thorax-caliper measurement: Pectus severity index (T.I.): (T3/T1) * 100 (%), T1: upper edge of the manubrium, T2: Angulus Ludovici, T3: deepest point of the funnel chest, Pectus carinatum: T.I. > 140. | Change from Pectus severity index at 12 weeks | |
Primary | patient's perception of deformity | patient's perception of deformity (0-10): The subject's self-perception of pectus carinatum was obtained through self-report using a scale from 0 (worst self-perception of pectus carinatum) to 10 (best self-perception of pectus carinatum). | Change from patient's perception of deformity at 12 weeks | |
Primary | Global Rating of Change Score | The responses for the Global Rating of Change Score is"much better (2)"; "slightly better(1)"; "stayed the same (0)";"slightly worse (-1)" or "much worse (-2)". | through study completion, an average of 12 weeks | |
Primary | Chest anthropometric measurement-1 | The extent of maximal protrusion:distance from the point of maximum protrusion to the estimated normal level of chest wall (milimeter). | Change from baseline the extent of maximal protrusion at 12 weeks | |
Secondary | New York Posture Rating Chart for posture assessment | The scores of the remaining 10 body alignment segments are summed, allowing a range ofoverall score between 0 and 100, with a score of 100 representing ideal posture | Change from baseline score of New York Posture Rating Chart at 12 weeks | |
Secondary | The Nuss Questionnaire modified for Adults (Patient Form) | Disease-specific health-related quality of life assessment tool for patients with pectus The patient version of the NQ-mA includes 12 items, scored 1 to 4. Possible minimum and maximum scores are 12 and 48 in the patient form; higher scores indicate a better quality of life. | Change from baseline score of The Nuss Questionnaire modified for Adults (Patient Form) at 12 weeks | |
Secondary | Chest anthropometric measurement-2 | Craniocaudal length: craniocaudal length of protruding zone, measured through the point of maximal protrusion | Change from baseline craniocaudal length at 12 weeks | |
Secondary | The Nuss Questionnaire modified for Adults (Parent Form) | Disease-specific health-related quality of life assessment tool for patients with pectus parent. The parent version of the NQ-mA includes 11 items, scored 1 to 4. Possible minimum and maximum scores are 11 and 44 in the parent form; higher scores indicate a better quality of life. | Change from baseline score of The Nuss Questionnaire modified for Adults (Parent Form) at 12 weeks | |
Secondary | Chest anthropometric measurement-3 | Lateral length: length of protruding zone, again measured through the point of maximum protrusion in the transverse direction | Change from baseline lateral length at 12 weeks |
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