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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02190331
Other study ID # SFRH/BD/77633/2011
Secondary ID
Status Completed
Phase N/A
First received July 11, 2014
Last updated July 14, 2014
Start date October 2012
Est. completion date October 2013

Study information

Verified date July 2014
Source Faculdade de Motricidade Humana
Contact n/a
Is FDA regulated No
Health authority Portugal: Health Ethic Committee
Study type Interventional

Clinical Trial Summary

- To evaluate the effects of a 32-weeks resistance and stretching training program applied in Physical Education classes on forward head and protracted shoulder Portuguese adolescents (15-17 years old).

- To evaluate on adolescents submitted to strength and stretching exercises the effects of a 16-week detraining period after the end of the intervention protocol.


Description:

A prospective, randomized and controlled study will be conducted over a 12 month period, with adolescents of two public secondary schools, in Lisbon.

At the beginning, a total of 275 adolescent students aged 15-17 years old will be evaluated with photogrammetry. The students will be screened by measuring the cervical (CV) and shoulder (SH) angle with photogrammetry. If the CV and SH angle were less than 50º and 52º respectively, the adolescent was considered to have forward head posture (FHP) and protracted shoulder (PS) and was selected to the study.

Participants will be excluded if their CV and SH angle was equal or higher than 50º and 52º respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic kyphosis.

After these the eligible students will be randomly assigned to the control or interventional group. The intervention group will begin a 32-week stretching and strengthening program to be performed in the last part of the Physical Education (PE) classes. The control group will only participate in the PE classes. Since the 32th week until the 48th week the experimental group will not follow the interventional training program and both groups will only participate in PE classes.

The program will be constituted by four strengthening exercises and three stretching exercises and is designed based on the assumption that the use of therapeutic exercise is effective in the correction of specific neck and shoulder postures. The training exercise protocol will be designed for the correction of the FHP and PS, targeting to the selective activation of lower trapezius, middle trapezius and rhomboids, to the lengthening of the pectoralis major, pectoralis minor and sternocleidomastoid and to the improvement of the deep cervical flexor function This program is going to be applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.

The postural assessment of the groups will be performed in the beginning and after 36 and 48-weeks intervention period.


Recruitment information / eligibility

Status Completed
Enrollment 275
Est. completion date October 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 17 Years
Eligibility Inclusion Criteria:

adolescents with 15-17 years old with cervical angle lower than 50º and the shoulder angle lower than 52º

Exclusion Criteria:

Participants were excluded if their CV and SH angle was equal or higher than 50º and 52º respectively, if they had visual deficits, diagnosed balance disorders, musculoskeletal pathologies, such as a history of shoulder surgery, cervical or thoracic fracture, were non-ambulatory, displayed functional or structural scoliosis, or had excessive thoracic kyphosis.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Interventional program postural correction training
The postural correction training program was applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.
Control Group physical education classes
Only performed the physical education classes

Locations

Country Name City State
Portugal Technical University of Lisbon Lisbon, Cruz Quebrada-Dafundo

Sponsors (1)

Lead Sponsor Collaborator
Faculdade de Motricidade Humana

Country where clinical trial is conducted

Portugal, 

Outcome

Type Measure Description Time frame Safety issue
Primary change in postural angles (cervical and shoulder angle) We will assess the Cervical angle - the angle formed at the intersection of a horizontal line through the spinous process of C7 and a line to the tragus of the ear and the shoulder angle - The angle formed at the intersection of the line between the midpoint of the humerus and the spinous process of C7 and the horizontal line through the midpoint of the humerus. 36 and 48 weeks Yes
Secondary the American Shoulder and Elbow Surgeons Standardized questionnaire 36 and 48 weeks Yes
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