NCT04438707

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2019

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
Last Updated

January 26, 2021

Status Verified

June 1, 2020

Enrollment Period

1 day

First QC Date

June 1, 2020

Last Update Submit

January 25, 2021

Conditions

Keywords

PilatesTherapeutic ExerciseChildrenString instrumentsVertebral column

Outcome Measures

Primary Outcomes (1)

  • SVA

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

    4 weeks

Secondary Outcomes (1)

  • Kinovea tool

    4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL
Other: Pilates Method combined with Therapeutic exercice.

Control group

ACTIVE COMPARATOR
Other: Therapeutic exercise

Interventions

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.

Experimental group

Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.

Control group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carolina Poncela

Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38111, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Carolina Poncela, Therapyst

    CEU San Pablo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Pilot study designed by a randomized controlled trial in two parallel intervention groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 19, 2020

Study Start

April 8, 2019

Primary Completion

April 9, 2019

Study Completion

September 25, 2020

Last Updated

January 26, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

We will show the study protocol, de statistical resulst done with SPSS and the informed consent form.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
When the study is finished and all the data are analized by SPSS. It will be available for 6 months.

Locations