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Trial registered on ANZCTR


Registration number
ACTRN12619000930189
Ethics application status
Approved
Date submitted
7/06/2019
Date registered
3/07/2019
Date last updated
3/07/2019
Date data sharing statement initially provided
3/07/2019
Date results information initially provided
3/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of custom-made foot orthoses in patients with Ehlers-Danlos Syndrome
Scientific title
The effects of custom-made foot orthotics on some manifestations related to Ehlers-Danlos Syndrome, such as foot pain, foot functionality, fatigue and quality of life.
Secondary ID [1] 298444 0
None
Universal Trial Number (UTN)
U1111-1234-9025
Trial acronym
FOEDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ehlers-Danlos Syndrome 313179 0
Foot deformities 313181 0
Foot pain 313325 0
Condition category
Condition code
Human Genetics and Inherited Disorders 311641 311641 0 0
Other human genetics and inherited disorders
Musculoskeletal 311808 311808 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weight-bearing phenolic foam molds of the feet were obtained by a podiatrist to make the custom-made foot orthoses. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, and an upper sheet of 40 Shore A, 3-mm thick polyethylene foam. The participants received instructions for the utilization of the foot orthotics at least 7 hours a day for 3 months.
Once a month, the participants were contacted by phone by one of two authors to make sure that they were following those instructions and to remind them about the importance of wearing the orthotics during the follow-up period.
Intervention code [1] 314687 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320348 0
Self-reported pain intensity over the last month was assessed with an 11-point Numeric Pain Rating Scale (NPRS).
Timepoint [1] 320348 0
These data were again collected after the 3-month follow-up period. 3 month post-baseline
Primary outcome [2] 320349 0
Disability related to foot pain was measured using the Manchester Foot Pain and Disability Index (MFPDI)
Timepoint [2] 320349 0
These data were again collected after the 3-month follow-up period. 3 month post-baseline
Secondary outcome [1] 371283 0
To evaluate the intensity of fatigue, the participants were asked to complete the Fatigue Severity Scale (FSS)
Timepoint [1] 371283 0
These data were again collected after the 3-month follow-up period. 3 month post-baseline
Secondary outcome [2] 371284 0
The SF-12 questionnaire was used to collect data about the quality of life.
Timepoint [2] 371284 0
These data were again collected after the 3-month follow-up period. 3 month post-baseline

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those with a neurologic disease, cognitive impairment or difficulties for an autonomous gait were excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The analysis of the data will carry out using the statistical software IBM SPSS Statistics 22 ® (IBM, Armonk, NY, USA). The descriptive data willprovide the mean values and the standard deviations, medians, and the absolute frequencies and percentages depending on whether the variables were scalar or categorical. Normality tests will conduct for the inferential analysis to determine the most appropriate test to use. Data will show an abnormal distribution, so non-parametric tests were carried out (Wilcoxon signed-rank test). The effect size will calculate using Rosenthal’s r to analyse the magnitude of the differences. The differences will classify according to the following for both parameters: below 0.2, no effect; 0.2-0.5, small effect; 0.5-0.8, medium effect; above 0.8, large effect. The confidence level a priori was 95%.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21582 0
Spain
State/province [1] 21582 0

Funding & Sponsors
Funding source category [1] 302989 0
University
Name [1] 302989 0
“VI PLAN PROPIO DE INVESTIGACIÓN Y TRANSFERENCIA - US 2018” of the University of Seville.
Address [1] 302989 0
San Fernando Street 4
CP 41004
Country [1] 302989 0
Spain
Primary sponsor type
University
Name
University of Seville
Address
San Fernando Street, 4
CP 41004
Country
Spain
Secondary sponsor category [1] 302951 0
None
Name [1] 302951 0
Address [1] 302951 0
Country [1] 302951 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303540 0
CEI de los Hospitales Universitarios Virgen Macarena y Virgen del Rocío
Ethics committee address [1] 303540 0
Avda. Dr. Fedriani, 3 - Unidad de Investigación 2ª planta Sevilla 41071 Sevilla España
Ethics committee country [1] 303540 0
Spain
Date submitted for ethics approval [1] 303540 0
31/01/2018
Approval date [1] 303540 0
08/06/2018
Ethics approval number [1] 303540 0

Summary
Brief summary
Pain and fatigue are major clinical manifestations in patients with Ehlers-Danlos Syndrome . The feet may be implicated in these symptoms and treating them could contribute to alleviating them.
The aims of this study is describe the effects of custom-made foot orthotics on some manifestations related to EDS, such as foot pain, foot functionality, fatigue and quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94018 0
Dr María Reina Bueno
Address 94018 0
University of Seville
Podiatry Departament
Avicena Street s/n
41009 Seville
Country 94018 0
Spain
Phone 94018 0
+34 954486544
Fax 94018 0
Email 94018 0
mreina1@us.es
Contact person for public queries
Name 94019 0
Dr María Reina Bueno
Address 94019 0
University of Seville
Podiatry Departament
Avicena Street s/n
41009 Seville
Country 94019 0
Spain
Phone 94019 0
+34 954486544
Fax 94019 0
Email 94019 0
mreina1@us.es
Contact person for scientific queries
Name 94020 0
Dr María Reina Bueno
Address 94020 0
University of Seville
Podiatry Departament
Avicena Street s/n
41009 Seville
Country 94020 0
Spain
Phone 94020 0
+34 954486544
Fax 94020 0
Email 94020 0
mreina1@us.es

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants will not be able to to share individual data.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2289 0
Ethical approval
Citation [1] 2289 0
Link [1] 2289 0
Email [1] 2289 0
Other [1] 2289 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary