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Pilates Method and Therapeutic Exercise in Children That Play String Instruments

Primary Purpose

Postural Kyphosis, Postural Lordosis, Postural Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pilates Method combined with Therapeutic exercice.
Therapeutic exercise
Sponsored by
CEU San Pablo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postural Kyphosis focused on measuring Pilates, Therapeutic Exercise, Children, String instruments, Vertebral column

Eligibility Criteria

10 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Carolina Poncela

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Outcomes

Primary Outcome Measures

SVA
to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.

Secondary Outcome Measures

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.

Full Information

First Posted
June 1, 2020
Last Updated
January 25, 2021
Sponsor
CEU San Pablo University
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1. Study Identification

Unique Protocol Identification Number
NCT04438707
Brief Title
Pilates Method and Therapeutic Exercise in Children That Play String Instruments
Official Title
Pilates Method and Therapeutic Exercise in Children That Play String Instruments: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 8, 2019 (Actual)
Primary Completion Date
April 9, 2019 (Actual)
Study Completion Date
September 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CEU San Pablo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postural Kyphosis, Postural Lordosis, Postural Low Back Pain
Keywords
Pilates, Therapeutic Exercise, Children, String instruments, Vertebral column

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study designed by a randomized controlled trial in two parallel intervention groups
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Pilates Method combined with Therapeutic exercice.
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
Primary Outcome Measure Information:
Title
SVA
Description
to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Kinovea tool
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Poncela, Therapyst
Organizational Affiliation
CEU San Pablo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Poncela
City
Tenerife
State/Province
Santa Cruz De Tenerife
ZIP/Postal Code
38111
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will show the study protocol, de statistical resulst done with SPSS and the informed consent form.
IPD Sharing Time Frame
When the study is finished and all the data are analized by SPSS. It will be available for 6 months.

Learn more about this trial

Pilates Method and Therapeutic Exercise in Children That Play String Instruments

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