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Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03960086
Recruitment Status : Completed
First Posted : May 22, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Fundacion Podoactiva

Tracking Information
First Submitted Date  ICMJE May 15, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date October 19, 2020
Actual Study Start Date  ICMJE June 12, 2019
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Visual analogical scale (VAS) [ Time Frame: At baseine and after the intervention period ]
    Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS)
  • Algometry [ Time Frame: At baseine and after the intervention period ]
    Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention
  • Sport activity pain perception [ Time Frame: At baseine and after the intervention period ]
    Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Foot Posture Index (FPI) [ Time Frame: At baseline ]
    values of Foot Posture Index (FPI) test in children with calcaneal apophysistis
  • lunge test values [ Time Frame: At baseline ]
    values of lunge test in children with calcaneal apophysistis
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis
Official Title  ICMJE Effectiveness of Custom-made Foot Orthoses vs Heel Lifts in Children With Calcaneal Apophysitis (Sever Disease): a Randomized Controlled Trial
Brief Summary

The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis. It examined the effect of custom-made foot orthoses and heel lifts in children with calcaneal apophysitis.

It was hypothesized that the primary outcome, pain relief, would be significantly improved with the custom-made orthosis compared to the heel lift.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Calcaneal Apophysitis
  • Sever's Disease
Intervention  ICMJE
  • Other: Podoactiva cutom-made foot orthoses
    Children had to use the orthotics daily during the intervention period
  • Other: Podoactiva heel lifts
    Children had to use the orthotics daily during the intervention period
Study Arms  ICMJE
  • Experimental: Custom-made foot orthoses

    Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.

    Treatment period of 12 weeks

    Intervention: Other: Podoactiva cutom-made foot orthoses
  • Active Comparator: Heel Lifts

    Children in the experimental group received as treatment intervention custom-made polypropylene foot orthoses (Podoactiva®, Spain). They were advised pragmatically to wear the orthoses at least 8 to 10 hours per day for the daily life and during sport activity.

    Treatment period of 12 weeks

    Intervention: Other: Podoactiva heel lifts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2019)
234
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 14, 2020
Actual Primary Completion Date December 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • diagnosed radiologically with calcaneal osteochondritis
  • diagnosed radiologically with calcaneal osteochondritis
  • have signed informed consent

Exclusion Criteria:

  • had suffered some trauma on the heel in the past 2 months
  • had received anti-inflammatory drugs and/or physical treatment for pain in the past 3 months
  • had presented physical or neurological impairment
  • were not interested
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03960086
Other Study ID Numbers  ICMJE Sever insoles-heel lifts
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No, participants in this study were not adults and in the informed consent signed there was not indiated this statment
Responsible Party Fundacion Podoactiva
Study Sponsor  ICMJE Fundacion Podoactiva
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fundacion Podoactiva
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP