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

January 5, 2018 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229
        • Maastricht UMC

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

12 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: orthosis
Device: orthosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
VAS-score
Time Frame: four weeks
four weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
lower extremities muscle ratio
Time Frame: four weeks
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

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

February 1, 2014

Primary Completion (Anticipated)

May 1, 2014

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

January 23, 2014

First Submitted That Met QC Criteria

January 5, 2018

First Posted (Actual)

January 12, 2018

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 5, 2018

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 133057

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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