Ignite Creation Date:
2024-05-06 @ 3:48 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02373553
Status:
UNKNOWN
Last Update Posted:
2015-03-03
First Post:
2015-02-23
Brief Title:
Impact of Physical Therapy Program in Mouthbreathing Children After Adenotonsillectomy
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Impact of Physical Therapy Program in Mouthbreathing Children After Adenotonsillectomy Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Although oral breathing children be studied by otolaryngologists allergists orthodontists speech therapists and physiotherapists and the prevalence of mouth breathing range from 266 to 533 in Brazilian studies physical medical and social problems arising from the Mouth Breathing SyndromeMB are still not recognized as a public health problem Behavioral changes in sleep quality and craniofacial development and consequently the quality of life after surgical orthodontic and multidisciplinary approach to the MB children are knownHowever little is known about the effectiveness of early physical therapy intervention whereas postural abnormalities characteristic of mouth breathing children are relevant and that the postural pattern adopted may persist into adulthood
SPECIFIC OBJECTIVES
1 Compare linear measurements of elevation scapular abduction and depression among MB children in preoperative and postoperative adenotonsillectomy
2 Compare the angular measurements of upper lower rotation external internal rotation anterior posterior tilt of the scapula and thoracic kyphosis protrusion and retraction of the head and shoulders of protrusion and retraction group of MB children preoperative and postoperative adenotonsillectomy 3 Evaluate the impact of physical therapy intervention postoperatively
STUDY DESIGN Cohort cross-sectional PARTICIPANTS The sample size calculation was based on the results of Correa et al 2008 who report similar to the effects of intervention proposed in this study45 children will be recruited from the Clinic of MOUTH BREATHING ARO of the Federal University of Minas Gerais UFMG To ensure adequate statistical power in case of loss to follow-up will be considered sample of 55 children
ELIGIBILITY CRITERIA 45 both male and female mouthbreathing children belonging to any racial group aged 4-10 years completed INCLUSION CRITERIA diagnosis of upper airway obstruction by endoscopy pharyngeal tonsil occupying 80 or more of the nasopharynx and or palatine tonsils 3 or 4 history of oral route of access and loss of passive lip seal display good understanding and whose family can signing the consent form approved by the Ethics Committee of the Federal University of Minas Gerais COEP
EXCLUSION CRITERIA children with neurological disorders or endocrine abnormalities that compromise the normal development of growth with the presence of ankylosis severe lung disease congenital heart defects craniofacial abnormalities with syndromic and who are unfit to perform the procedures proposed in this study
PROCEDURES Assessment and endoscopy will be held at ARO UFMG where children will be screened according to the inclusion and exclusion criteria of this study After passing the COEP officials who accept to participate in the study must sign the Instrument of Consent The collection of kinematic data will be held in the Motion Analysis Laboratory Department of Physical Therapy The physiotherapy intervention will be held at ARO who works regularly on Thursdays for a period of three months
STUDY PROTOCOL Demographic and clinical data will be collected from all participants All the measure proposed below will be obtained previously T0 and three months after surgery T1 By completing measures based process randomisation will be performed and the patients will be divided into 3 groups GROUP 1G1 - without physical interventions only oral health education GROUP 2 G2- guidance booklet for home with some stretched exercises and GROUP 3G3 exercises -physiotherapy intervention proposal for a period of three months After three months of allocation groups G1 G2 and G3 new measures will be carried out T2 Those children who are identified with persistent postural changes will be forwarded to continue the specialized treatmentThe G3 will be submitted to the postural reeducation through lengthening of the anterior muscles and strengthening of the posterior muscles of the trunk 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 G2 family will receive a booklet of guidance of exercises to be performed at home and the G3 will not receive targeted intervention
MEASURES The kinematics of the shoulder girdle cervical and thoracic spine of the participants will be obtained through the System Qualysis ProReflex in 3 times regarding reliability This is a photogrammetry system based on video that has four cameras with illumination stroboscopy produced by a group of infrared reflectors located around the lens of each camera Infrared light designed for each camera is reflected by passive markers placed on specific points or anatomical points on the body of the participants The reflection of light on passive markers is captured by cameras generating a two-dimensional 2D image of the respective positions of these markers The triangulation of the images of at least two cameras allows the reconstruction in three dimensions 3D passive reflective of brands Data obtained are processed by the Track Manager software Subsequently data are transferred to the Mat Lab program Matrix Laboratory software where the angular measurements are calculated using the arc tangent function For the measurements of the orientation of the cervical spine scapula and thoracic spine sixteen reflective tags are used 15mm diameter
TITLEThe orientation of the scapula includes three angular measurements lower and upper rotation anterior posterior tilt internal rotation external and two linear measurements elevation and abduction Upward rotation U-Rot A occurs perpendicularly to the anterior-posterior axis and corresponds to the lateralization of the inferior angle of the scapula in relation to the spinal column on the frontal plane such that the glenoid cavity is oriented upwardly Angle A was obtained from the intersection of a straight line passing through the C7 and T7 markers a straight line passing through the medial edge of the scapula over the markers on the root of the spine and a marker over the inferior angle of the scapulaScapular abduction S-Abd lateral shift of the scapula in relation to the spinal column Horizontal distance B in millimeters from the centroid point of the scapula to the spinal column Greater distance between markers indicated greater scapular abductionScapular elevation S-Ele linear upward shift of the scapular over the thoracic cage C was obtained from the vertical distance in millimeters from the marker positioned over C7 to the centroid point of the scapula Greater scapular elevation indicated a lesser distance between markers Measures of kyphosis of the thoracic spine protraction retraction and protraction of the head shoulder retraction will also be undertaken
TIME FRAME 3 months after each assessment with safety issue INTERVENTION PROTOCOLS The G3 will be submitted to the postural reeducation through lengthening of the anterior muscles and strengthening of the posterior muscles of the trunk 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 G2 family will receive a booklet of guidance of exercises to be performed at home and the G1 group did not receive intervention
SPECIFIC OBJECTIVES
1 Compare linear measurements of elevation scapular abduction and depression among MB children in preoperative and postoperative adenotonsillectomy
2 Compare the angular measurements of upper lower rotation external internal rotation anterior posterior tilt of the scapula and thoracic kyphosis protrusion and retraction of the head and shoulders of protrusion and retraction group of MB children preoperative and postoperative adenotonsillectomy 3 Evaluate the impact of physical therapy intervention postoperatively
STUDY DESIGN Cohort cross-sectional PARTICIPANTS The sample size calculation was based on the results of Correa et al 2008 who report similar to the effects of intervention proposed in this study45 children will be recruited from the Clinic of MOUTH BREATHING ARO of the Federal University of Minas Gerais UFMG To ensure adequate statistical power in case of loss to follow-up will be considered sample of 55 children
ELIGIBILITY CRITERIA 45 both male and female mouthbreathing children belonging to any racial group aged 4-10 years completed INCLUSION CRITERIA diagnosis of upper airway obstruction by endoscopy pharyngeal tonsil occupying 80 or more of the nasopharynx and or palatine tonsils 3 or 4 history of oral route of access and loss of passive lip seal display good understanding and whose family can signing the consent form approved by the Ethics Committee of the Federal University of Minas Gerais COEP
EXCLUSION CRITERIA children with neurological disorders or endocrine abnormalities that compromise the normal development of growth with the presence of ankylosis severe lung disease congenital heart defects craniofacial abnormalities with syndromic and who are unfit to perform the procedures proposed in this study
PROCEDURES Assessment and endoscopy will be held at ARO UFMG where children will be screened according to the inclusion and exclusion criteria of this study After passing the COEP officials who accept to participate in the study must sign the Instrument of Consent The collection of kinematic data will be held in the Motion Analysis Laboratory Department of Physical Therapy The physiotherapy intervention will be held at ARO who works regularly on Thursdays for a period of three months
STUDY PROTOCOL Demographic and clinical data will be collected from all participants All the measure proposed below will be obtained previously T0 and three months after surgery T1 By completing measures based process randomisation will be performed and the patients will be divided into 3 groups GROUP 1G1 - without physical interventions only oral health education GROUP 2 G2- guidance booklet for home with some stretched exercises and GROUP 3G3 exercises -physiotherapy intervention proposal for a period of three months After three months of allocation groups G1 G2 and G3 new measures will be carried out T2 Those children who are identified with persistent postural changes will be forwarded to continue the specialized treatmentThe G3 will be submitted to the postural reeducation through lengthening of the anterior muscles and strengthening of the posterior muscles of the trunk 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 G2 family will receive a booklet of guidance of exercises to be performed at home and the G3 will not receive targeted intervention
MEASURES The kinematics of the shoulder girdle cervical and thoracic spine of the participants will be obtained through the System Qualysis ProReflex in 3 times regarding reliability This is a photogrammetry system based on video that has four cameras with illumination stroboscopy produced by a group of infrared reflectors located around the lens of each camera Infrared light designed for each camera is reflected by passive markers placed on specific points or anatomical points on the body of the participants The reflection of light on passive markers is captured by cameras generating a two-dimensional 2D image of the respective positions of these markers The triangulation of the images of at least two cameras allows the reconstruction in three dimensions 3D passive reflective of brands Data obtained are processed by the Track Manager software Subsequently data are transferred to the Mat Lab program Matrix Laboratory software where the angular measurements are calculated using the arc tangent function For the measurements of the orientation of the cervical spine scapula and thoracic spine sixteen reflective tags are used 15mm diameter
TITLEThe orientation of the scapula includes three angular measurements lower and upper rotation anterior posterior tilt internal rotation external and two linear measurements elevation and abduction Upward rotation U-Rot A occurs perpendicularly to the anterior-posterior axis and corresponds to the lateralization of the inferior angle of the scapula in relation to the spinal column on the frontal plane such that the glenoid cavity is oriented upwardly Angle A was obtained from the intersection of a straight line passing through the C7 and T7 markers a straight line passing through the medial edge of the scapula over the markers on the root of the spine and a marker over the inferior angle of the scapulaScapular abduction S-Abd lateral shift of the scapula in relation to the spinal column Horizontal distance B in millimeters from the centroid point of the scapula to the spinal column Greater distance between markers indicated greater scapular abductionScapular elevation S-Ele linear upward shift of the scapular over the thoracic cage C was obtained from the vertical distance in millimeters from the marker positioned over C7 to the centroid point of the scapula Greater scapular elevation indicated a lesser distance between markers Measures of kyphosis of the thoracic spine protraction retraction and protraction of the head shoulder retraction will also be undertaken
TIME FRAME 3 months after each assessment with safety issue INTERVENTION PROTOCOLS The G3 will be submitted to the postural reeducation through lengthening of the anterior muscles and strengthening of the posterior muscles of the trunk 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 G2 family will receive a booklet of guidance of exercises to be performed at home and the G1 group did not receive intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None