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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04438707
Other study ID # CEUSP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 8, 2019
Est. completion date September 25, 2020

Study information

Verified date June 2020
Source CEU San Pablo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Introduction: An inappropriate posture in children for a while kept playing some instrument of the group of the rubbed string, can cause pain and alterations of the spine, as it continues to consolidate. Objective: To study the benefits acquired during the application of the Pilates Method combined with therapeutic exercise against the Therapeutic Exercise to reduce alterations of the vertebral rachis in children from 10 to 14 years old who play instruments of rubbed strings.


Description:

Material and methods: A pilot study designed by a randomized controlled trial in two parallel intervention groups was carried out; 9 children performed the combination of the Pilates Method and Therapeutic Exercise (experimental) and 7 children performed the Therapeutic Exercise (control). At the beginning and at the end of the study, pain measurements have been made through the Visual Analogue Scale (EVA), and the Kinovea programme for the alignment of shoulder, scapula and hip postures.


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date September 25, 2020
Est. primary completion date April 9, 2019
Accepts healthy volunteers No
Gender All
Age group 10 Years to 14 Years
Eligibility Inclusion Criteria: - Subjects with typical development and ages between 10 and 14 years old. - Subjects who play the violin, viola, cello or double bass. Subjects who have learned to play the violin, viola, cello or double bass in this school year or up to a maximum of four previous years, eligible to receive Pilates classes. - Subjects with cognitive ability to understand simple orders. - Subjects who are enrolled this year in Orchestrated Neighborhoods. Exclusion Criteria: - Subjects whose ages are not between 10 and 14 years of age. - Subjects who do not play the violin, viola, cello, or double bass.Subjects who have more than four school years playing the violin, viola, cello or double bass. - Subjects who do not have cognitive capacity to understand simple orders. - Subjects who are not registered this year in Orchestrated Neighborhoods. - Subjects who do not complete the four sessions of Therapeutic Exercise + Pilates or Therapeutic Exercise.

Study Design


Intervention

Other:
Pilates Method combined with Therapeutic exercice.
Children must perform specific exercices in this combined method with the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
Therapeutic exercise
Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.

Locations

Country Name City State
Spain Carolina Poncela Tenerife Santa Cruz De Tenerife

Sponsors (1)

Lead Sponsor Collaborator
CEU San Pablo University

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary SVA to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity. 4 weeks
Secondary Kinovea tool to assess the alignement in shoulders, hips. It meusered in degrees of movement to observe the amplitud in the movemente and the simetry of joints. It is used a software to analyse the information and obtain the posture in the child. 4 weeks
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