Child, OnlyNCT03629821
Effect of Classic Ballet Practice on School Children's Postural Balance
A study testing Ballet in people with Child, Only, run by Universidade Federal de Santa Maria at 1 site in Brazil.
Trial summary
Is a parallel longitudinal protocol where half patients receive a experimental protocol and the other half receive orientation to maintain your daily live routine as usually. The experimental protocol include Ballet sessions. Read more about this study
- Who is it for?
- Ages 9 to 12 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Child, Only
- What is being tested?
- Ballet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Jul 2018to 30 Nov 2022
- 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 9 to 12 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- Female sex
- 9 to 12 years of age
Who cannot join
- Musculoskeletal pain at last 3 months
- Perform other physical activity besides scholar's physical activity
- Has been participated Ballet class.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Classic Ballet Practice on School Children's Postural Balance: Randomized Clinical Trial
Is a parallel longitudinal protocol where half patients receive a experimental protocol and the other half receive orientation to maintain your daily live routine as usually. The experimental protocol include Ballet sessions. The hypothesis is interventional group will improve the balance control more than control group.
- Conditions
- Child, Only
- Being tested
- Ballet
- Keywords
- Postural Balance, Dance Therapy, Exercise Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalletOther
The classic ballet classes will respect biological limits of children. The sessions will be 75 minutes long, twice a week during 8 weeks. The class sequence will be: warm-up, follow by exercises about upper and lower limbs ballet positions and sequences of ballet jumps, and at the end a cool-down.
| Study group | Role | What they receive |
|---|---|---|
| Ballet | Experimental | Subjects who will receive the experimental protocol. Receives: Other: Ballet |
| Control | No intervention | Subjects who will not receive the experimental protocol, only will be on a wait list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total score of Star Excursion Balance Test at 8 weeks.
Changing between the beginning and end of intervention. This measure is shown in cm.
Measured: Before, immediate after intervention protocol
Change from baseline in anteriorposterior and mediolateral displacements of Pressure Center at 8 weeks.
Changing between the beginning and end of intervention of anteroposterior and mediolateral displacements of pressure center in cm.
Measured: Before, immediate after intervention protocol
Change from baseline in average speed of Pressure Center at 8 weeks.
Changing between the beginning and end of average speed of pressure center in cm/s.
Measured: Before, immediate after intervention protocol
Change from baseline in 95% ellipse area of Pressure Center at 8 weeks.
Changing between the beginning and end of 95% ellipse area of pressure center in cm².
Measured: Before, immediate after intervention protocol
Maintenance at 30 and 60 days from baseline in total score of Star Excursion Balance Test.
Changing between the end and 30 and 60 days after intervention. This measure is shown in cm.
Measured: Immediate after, 30 and 60 days after intervention protocol.
Maintenance at 30 and 60 days from baseline in anteroposterior and mediolateral displacements of pressure center
Changing between the end and 30 and 60 days after intervention of anteroposterior and mediolateral displacements of pressure center in cm.
Measured: Immediate after, 30 and 60 days after intervention protocol.
Maintenance at 30 and 60 days from baseline in average speed of pressure center
Changing between the end and 30 and 60 days after intervention of average speed of pressure center in cm/s.
Measured: Immediate after, 30 and 60 days after intervention protocol.
Maintenance at 30 and 60 days from baseline in 95% ellipse area of pressure center
Changing between the end and 30 and 60 days after intervention of 95% ellipse area of pressure center in cm².
Measured: Immediate after, 30 and 60 days after intervention protocol.
Secondary outcomes (2)
Vertical stiffness
Stiffness estimate by force plate data and displament of center of mass
Measured: Before, immediate after, 30 and 60 days after intervention protocol
Peak and absortion rate of ground reaction force
Greatest value and absortion rate (between inicial contat and peak) of ground reaction force
Measured: Before, immediate after, 30 and 60 days after intervention protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start15 Jul 2018
- Primary completion30 Oct 2018
- Study completion30 Nov 2022 (estimated)
Why it stopped: The study has been suspended because COVID pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child, OnlyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups design where one group receives treatment and the other not in the same period of time.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karine Josibel Velasques Stoelben, Universidade Federal do Pampa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629821
- Sponsor's protocol ID
- 65327017.2.0000.5346
- Status last verified
- Nov 2020
- First submitted
- 11 Jun 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Classic Ballet Practice on School Children's Postural Balance: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03629821
- Acronym / sponsor ID
- 65327017.2.0000.5346
- Conditions
- Child, Only
- Keywords
- Postural Balance, Dance Therapy, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The study has been suspended because COVID pandemic.
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 15 Jul 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 14 Aug 2018 (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.
Is a parallel longitudinal protocol where half patients receive a experimental protocol and the other half receive orientation to maintain your daily live routine as usually. The experimental protocol include Ballet sessions. The hypothesis is interventional group will improve the balance control more than control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups design where one group receives treatment and the other not in the same period of time.
| Arm | Type | Receives |
|---|---|---|
| Ballet | Experimental | Other: BalletSubjects who will receive the experimental protocol. |
| Control | No intervention | –Subjects who will not receive the experimental protocol, only will be on a wait list. |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Female sex
- 9 to 12 years of age
Key exclusion criteria (3 listed)
- Musculoskeletal pain at last 3 months
- Perform other physical activity besides scholar's physical activity
- Has been participated Ballet class.
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 |
|---|---|---|
| BalletThe classic ballet classes will respect biological limits of children. The sessions will be 75 minutes long, twice a week during 8 weeks. The class sequence will be: warm-up, follow by exercises about upper and lower limbs ballet positions and sequences of ballet jumps, and at the end a cool-down. | Other | Ballet |
Primary outcome
Change from baseline in total score of Star Excursion Balance Test at 8 weeks.
Time frame: Before, immediate after intervention protocol
Changing between the beginning and end of intervention. This measure is shown in cm.
Change from baseline in anteriorposterior and mediolateral displacements of Pressure Center at 8 weeks.
Time frame: Before, immediate after intervention protocol
Changing between the beginning and end of intervention of anteroposterior and mediolateral displacements of pressure center in cm.
Change from baseline in average speed of Pressure Center at 8 weeks.
Time frame: Before, immediate after intervention protocol
Changing between the beginning and end of average speed of pressure center in cm/s.
Change from baseline in 95% ellipse area of Pressure Center at 8 weeks.
Time frame: Before, immediate after intervention protocol
Changing between the beginning and end of 95% ellipse area of pressure center in cm².
Maintenance at 30 and 60 days from baseline in total score of Star Excursion Balance Test.
Time frame: Immediate after, 30 and 60 days after intervention protocol.
Changing between the end and 30 and 60 days after intervention. This measure is shown in cm.
Maintenance at 30 and 60 days from baseline in anteroposterior and mediolateral displacements of pressure center
Time frame: Immediate after, 30 and 60 days after intervention protocol.
Changing between the end and 30 and 60 days after intervention of anteroposterior and mediolateral displacements of pressure center in cm.
Maintenance at 30 and 60 days from baseline in average speed of pressure center
Time frame: Immediate after, 30 and 60 days after intervention protocol.
Changing between the end and 30 and 60 days after intervention of average speed of pressure center in cm/s.
Maintenance at 30 and 60 days from baseline in 95% ellipse area of pressure center
Time frame: Immediate after, 30 and 60 days after intervention protocol.
Changing between the end and 30 and 60 days after intervention of 95% ellipse area of pressure center in cm².
2 secondary outcomes
Vertical stiffness
Time frame: Before, immediate after, 30 and 60 days after intervention protocol
Peak and absortion rate of ground reaction force
Time frame: Before, immediate after, 30 and 60 days after intervention protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ballet in people with Child, Only, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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 2 inclusion and 3 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: paused, as of the sponsor's last update on 6 Nov 2020. 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 Brazil. 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?
Results are not available in the source record.
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?
Change from baseline in total score of Star Excursion Balance Test at 8 weeks. (time frame: Before, immediate after intervention protocol). The study lists 8 primary outcomes in all. 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 6 Nov 2020.