NCT02373553

Brief Summary

MB Children maintains the same postural pattern in preoperative and postoperative adenotonsillectomy? The age influences the incidence of more exacerbated postural changes? The proposed early physiotherapy intervention can minimize future functional deficits? Trying to answer some of these questions, the objective of present study is to investigate the initial kinematics of the shoulder girdle, cervical and thoracic spine in MB children pre and post adenotonsillectomy and then evaluate the effects of a physical therapy intervention program for MB children who persisted with postural changes.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 3, 2015

Status Verified

March 1, 2015

Enrollment Period

4 months

First QC Date

February 23, 2015

Last Update Submit

March 2, 2015

Conditions

Keywords

postureposturalkinetics

Outcome Measures

Primary Outcomes (1)

  • Angular and linear Measurement position of head, scapular and kyphosis

    1 year

Secondary Outcomes (1)

  • ages influences in this postural disorders

    6 months

Study Arms (3)

Group 1( G1): CONTROL GROUP

NO INTERVENTION

not be submitted to intervention, only receive informations about health education.

Group 2(G2) : HEALTH EDUCATION

EXPERIMENTAL

The family will receive a booklet of guidance of exercises to be performed at home.

Other: HEALTH EDUCATION

Group 3(G3): EXERCISES IN OUTPATIENTS UNIT

EXPERIMENTAL

The postural reeducation through lengthening of the anterior muscles and strengthening of the posterior muscles of the trunk.

Other: EXERCISES

Interventions

The postural reeducation in a sitting position, in ventral and dorsal recumbency, including manual techniques, stretching the sternocleidomastoid and scalene muscles. Exercises for pelvic girdle positioning and stretching the hamstrings muscles tibial and sural triceps are associated with respiratory exercise. Twice a week during 3 months

Group 3(G3): EXERCISES IN OUTPATIENTS UNIT

Booklet contain many pictures demonstrating some exercises and an importance to do it.

Group 2(G2) : HEALTH EDUCATION

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270901, Brazil

Location

Federal University of Minas Gerais

Belo Horizonte, Minas Gerais, 31270910, Brazil

Location

Related Publications (1)

  • 1. Stokes, N. and Della, Mattia D. A student research review of the mouthbreathing habit: discussing measurement methods, manifestations and treatment of the mouthbreathing habit. Probe., v. 30, n. 6, p. 212-214, 1996. 2. Francesco, R. C., Passerotii, G., Paulucci, B., and Miniti, A. Respiração Oral na Criança:Repercussões diferentes de acordo com o diagnóstico. Rev.Bras.Otorrinolaringol., v. 70, n. 5, p. 665-670, 2004. 3. Aragao, W. Aragao's function regulator, the stomatognathic system and postural changes in children. J.Clin.Pediatr.Dent., v. 15, n. 4, p. 226-231, 1991. 4. Fujiki, P and R. Influência da hipertrofia adenoideana no crescimento e desenvolvimento craniodentofacial. Ortodontia, v. 32, n. 1, p. 70-77, 1999. 5.Lourenco, E. A. and Lopes, K. C. (1-2-2005). Estudo comparativo radiológico e nasofibroscópico do volume adenoideano em crianças respiradoras orais. Rev.Bras.Otorrinolaringol. 71[1], 23-28. 6. Lima, LCO, Baraúna, MA., Sologurem, MJJ, Canto, RST, and Gastaldi, AC. Postural alterations in children with mouth breathing assessed by computerized biophotogrammetry. J.Appl.Oral Sci., v. 12, n. 3, p. 232-237, 2004. 7. Krakauer, L. H. and Guilherme, A. Relationship between mouth breathing and postural alterations of children: a descriptive analysis. Int.J.Orofacial.Myology., v. 26, p. 13-23, 2000. 8. Yi, LC Pignatari S and Weckx LLM. Avaliação postural em crianças de 5 a 12 anos que apresentam respiração oral. Fisioterapia em movimento, v. 16, n. 3, p. 29-33, 2003. 9. Neiva PD, Kirkwood RN, Godinho R. Orientation and position of head posture, scapula and thoracic spine in mouth-breathing children. Int J Pediatr Otorhinolaryngol. 2009; 73:227-36.

    BACKGROUND

MeSH Terms

Conditions

Mouth Breathing

Interventions

Exercise

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Patricia D Neiva, MD

    Federal University of Minas Gerais

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree in Rehabilitation Sciense

Study Record Dates

First Submitted

February 23, 2015

First Posted

February 27, 2015

Study Start

October 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2016

Last Updated

March 3, 2015

Record last verified: 2015-03

Locations