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

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000930189
Acronym
FOEDS
Enrollment
41
Registered
2019-07-03
Start date
2018-06-11
Completion date
2018-10-18
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 w

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.

Sponsors

University of Seville
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026