Pilates Method and Therapeutic Exercise in Children That... | NCT04438707

Studies
Pilates Method and Therapeutic Exercise in Children That Play String Instruments

NCT04438707

Sponsor

CEU San Pablo University

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Postural Kyphosis
Postural Lordosis
Postural Low Back Pain

Interventions

Pilates Method combined with Therapeutic exercice.
Therapeutic exercise

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2019Actual

Primary Completion Date

Apr 9, 2019Actual

Completion Date

Sep 25, 2020Actual

First Submitted Date

Jun 1, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 19, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental group	Experimental		Other: Pilates Method combined with Therapeutic exercice.
Control group	Active Comparator		Other: Therapeutic exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pilates Method combined with Therapeutic exercice.	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
SVA	to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.	4 weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carolina Poncela, Therapyst	CEU San Pablo University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carolina Poncela		Santa Cruz de Tenerife	Santa Cruz De Tenerife	38111	Spain

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

When the study is finished and all the data are analized by SPSS. It will be available for 6 months.

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005081	Exercise Therapy

Ancestor Terms

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided