Postural KyphosisNCT04438707
Pilates Method and Therapeutic Exercise in Children That Play String Instruments
A study testing Pilates Method combined with Therapeutic exercice. and Therapeutic exercise in people with Postural Kyphosis and Postural Lordosis, run by CEU San Pablo University at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Postural Kyphosis, Postural Lordosis, Postural Low Back Pain
- What is being tested?
- Pilates Method combined with Therapeutic exercice. and Therapeutic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSpain
- Study dates
- 8 Apr 2019to 25 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Carolina Poncela
Santa Cruz de Tenerife, Santa Cruz De Tenerife, 38111
About this study
Official title: Pilates Method and Therapeutic Exercise in Children That Play String Instruments: Pilot Study
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.
Read the 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.
- Conditions
- Postural Kyphosis, Postural Lordosis, Postural Low Back Pain
- Being tested
- Pilates Method combined with Therapeutic exercice., Therapeutic exercise
- Keywords
- Pilates, Therapeutic Exercise, Children, String instruments, Vertebral column
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Therapeutic exerciseOther
Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Other: Pilates Method combined with Therapeutic exercice. |
| Control group | Active comparator | Not described Receives: Other: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVA
to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start8 Apr 2019
- Primary completion9 Apr 2019
- Study completion25 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural KyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study designed by a randomized controlled trial in two parallel intervention groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CEU San Pablo University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolina Poncela, Therapyst, Principal investigator, CEU San Pablo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438707
- Sponsor's protocol ID
- CEUSP
- Status last verified
- Jun 2020
- First submitted
- 1 Jun 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will show the study protocol, de statistical resulst done with SPSS and the informed consent form.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Method and Therapeutic Exercise in Children That Play String Instruments: Pilot Study
- ClinicalTrials.gov ID
- NCT04438707
- Acronym / sponsor ID
- CEUSP
- Conditions
- Postural Kyphosis, Postural Lordosis, Postural Low Back Pain
- Keywords
- Pilates, Therapeutic Exercise, Children, String instruments, Vertebral column
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CEU San Pablo UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 25 Sep 2020 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study designed by a randomized controlled trial in two parallel intervention groups
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Pilates Method combined with Therapeutic exercice. |
| Control group | Active comparator | Other: Therapeutic exercise |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental group |
| Therapeutic exerciseChildren must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks. | Other | Control group |
Primary outcome
SVA
Time frame: 4 weeks
to assess the pain in children. The child must choose a number (0-10) depending of the pain intensity.
1 secondary outcome
Kinovea tool
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: Yes. We will show the study protocol, de statistical resulst done with SPSS and the informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolina Poncela, Therapyst principal investigator
CEU San Pablo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Method combined with Therapeutic exercice. and Therapeutic exercise in people with Postural Kyphosis and Postural Lordosis, run by CEU San Pablo University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVA (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.