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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Custom-made foot orthoses | Experimental | 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 |
|
| Heel Lifts | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Podoactiva cutom-made foot orthoses | Other | Children had to use the orthotics daily during the intervention period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogical scale (VAS) | Subjective Sever´s disease pain perception before and after the intervention measured by the Visual analogical scale (VAS) | At baseine and after the intervention period |
| Algometry | Pressure-pain threshold measured in the heel in Sever´s disease, before and after the intervention | At baseine and after the intervention period |
| Sport activity pain perception | Sever´s disease pain perception measured asking the following question: "Do you have pain at sport activity?", before and after intervention | At baseine and after the intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Foot Posture Index (FPI) | values of Foot Posture Index (FPI) test in children with calcaneal apophysistis | At baseline |
| lunge test values | values of lunge test in children with calcaneal apophysistis |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alejandro Jesús Almenar Arasanz | Zaragoza | 50001 | Spain |
No, participants in this study were not adults and in the informed consent signed there was not indiated this statment
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 15, 2018 | May 21, 2019 | Prot_SAP_000.pdf |
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The study was a parallel-group, randomized controlled trial with concealed allocation, blinding of investigators and assessors and intention-to-treat analysis.
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| Podoactiva heel lifts | Other | Children had to use the orthotics daily during the intervention period |
|
| At baseline |