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The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes

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ClinicalTrials.gov Identifier: NCT03397927
Recruitment Status : Withdrawn (No response to EC questions were given)
First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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Brief Summary:

An orthosis in the ballet shoe to see if pain reduction during dancing on pointes will decrease.

One group of pre-preprofessional ballet dancers will receive an orthosis and will train during four weeks with it. The other group without a orthosis will be the control group.


Condition or disease Intervention/treatment Phase
Ballet Dancers Device: orthosis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Improved Ballet Shoe: a Study on the Effect of an Orthosis on Pain During Dancing on Pointe Shoes
Study Start Date : February 2014
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : June 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: orthosis Device: orthosis


Outcome Measures
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Primary Outcome Measures :
  1. VAS-score [ Time Frame: four weeks ]

Secondary Outcome Measures :
  1. lower extremities muscle ratio [ Time Frame: four weeks ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • girls on preprofessional ballet schools with a minimum of 30 minutes professional training a week;
  • 12 to 18 years old
  • pain during dancing on pointes

Exclusion Criteria:

  • experience with wearing a orthosis in their ballet shoe
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397927


Locations
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Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands, 6229
Sponsors and Collaborators
Maastricht University Medical Center
More Information
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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03397927    
Other Study ID Numbers: 133057
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2014
Keywords provided by Maastricht University Medical Center:
ballet shoe
orthosis
pain