- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03629821
Effect of Classic Ballet Practice on School Children's Postural Balance
November 4, 2020 updated by: Karine Josibel Velasques Stoelben, Universidade Federal de Santa Maria
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
RS
-
Santa Maria, RS, Brazil, 97105900
- Kelen Munhos Pinto
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female sex
- 9 to 12 years of age
Exclusion Criteria:
- Musculoskeletal pain at last 3 months
- Perform other physical activity besides scholar's physical activity
- Has been participated Ballet class.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ballet
Subjects who will receive the experimental protocol.
|
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.
|
No Intervention: Control
Subjects who will not receive the experimental protocol, only will be on a wait list.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Before, immediate after intervention protocol
|
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.
|
Before, immediate after intervention protocol
|
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.
|
Before, immediate after intervention protocol
|
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.
|
Before, immediate after intervention protocol
|
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.
|
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
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.
|
Immediate after, 30 and 60 days after intervention protocol.
|
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.
|
Immediate after, 30 and 60 days after intervention protocol.
|
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.
|
Immediate after, 30 and 60 days after intervention protocol.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vertical stiffness
Time Frame: Before, immediate after, 30 and 60 days after intervention protocol
|
Stiffness estimate by force plate data and displament of center of mass
|
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
|
Greatest value and absortion rate (between inicial contat and peak) of ground reaction force
|
Before, immediate after, 30 and 60 days after intervention protocol
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical activity level
Time Frame: Before intervention
|
Assessed by final score of Physical Activity Questionnaire for Children.
The score questions are about daily physical activity of children.
Final score is a mean calculate by 9 items/questions with range 1 to 5. A final score of 1 (minimum) indicates low physical activity, whereas a score of 5 (maximum) indicates high physical activity.
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Before intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2018
Primary Completion (Actual)
October 30, 2018
Study Completion (Anticipated)
November 30, 2022
Study Registration Dates
First Submitted
June 11, 2018
First Submitted That Met QC Criteria
August 9, 2018
First Posted (Actual)
August 14, 2018
Study Record Updates
Last Update Posted (Actual)
November 6, 2020
Last Update Submitted That Met QC Criteria
November 4, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 65327017.2.0000.5346
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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