NCT03397927

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

January 12, 2018

Completed
Last Updated

January 12, 2018

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

January 23, 2014

Last Update Submit

January 5, 2018

Conditions

Ballet Dancers

Keywords

ballet shoeorthosispain

Outcome Measures

Primary Outcomes (1)

  • VAS-score

    four weeks

Secondary Outcomes (1)

  • lower extremities muscle ratio

    four weeks

Study Arms (1)

orthosis

EXPERIMENTAL
Device: orthosis

Interventions

orthosisDEVICE
orthosis

Eligibility Criteria

Age12 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • experience with wearing a orthosis in their ballet shoe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht UMC

Maastricht, Limburg, 6229, Netherlands

Location

MeSH Terms

Conditions

Pain

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 12, 2018

Study Start

February 1, 2014

Primary Completion

May 1, 2014

Study Completion

June 1, 2014

Last Updated

January 12, 2018

Record last verified: 2014-01

Locations

NL(1)