Effectiveness of custom-made foot orthoses in patients with Ehlers-Danlos Syndrome

Not Applicable

Completed

• Conditions: Ehlers-Danlos Syndrome; Foot deformities; Foot pain; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12619000930189
• Lead Sponsor: niversity of Seville

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-02-08
• Study Start: 2019-07-03
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Participants for this study had to be adults with Ehlers-Danlos syndrome diagnosed by a medical specialist, and with self-reported foot symptoms.

Exclusion Criteria

Those with a neurologic disease, cognitive impairment or difficulties for an autonomous gait were excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported pain intensity over the last month was assessed with an 11-point Numeric Pain Rating Scale (NPRS).[These data were again collected after the 3-month follow-up period. 3 month post-baseline];Disability related to foot pain was measured using the Manchester Foot Pain and Disability Index (MFPDI) [These data were again collected after the 3-month follow-up period. 3 month post-baseline]

Secondary Outcome Measures

Name	Time	Method
To evaluate the intensity of fatigue, the participants were asked to complete the Fatigue Severity Scale (FSS) [These data were again collected after the 3-month follow-up period. 3 month post-baseline];The SF-12 questionnaire was used to collect data about the quality of life.[These data were again collected after the 3-month follow-up period. 3 month post-baseline]