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The mechanical effect of the EXO-L device for functional ankle instability

The mechanical effect of the EXO-L device for functional ankle instability - EXO-L

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40444
Enrollment
22
Registered
2014-04-03
Start date
2014-05-02
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

functional ankle instability repeated ankle sprain

Interventions

The intervetnion is the application of EXO-L. Each subjects is his own control. The measurements are performed with and without EXO-L.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age of 18 years or more History of ankle inversion instability, as determined from clinical history Ability to read and understand the subject information Received, used and familiar with EXO-L in combination with an appropriately customized sports shoe

Exclusion criteria

Exclusion criteria: Sustained ankle injury in the past two months History of rheumatic disease History of surgical intervention in the ankle or foot for any indication Constitutional hyperlaxity by clinical examiniation For females: pregnancy or the aim of becoming pregnant

Design outcomes

Primary

MeasureTime frame
The outcome are values for the effect of the EXO-L device on the ranges of motion from extreme dorsal to plantar flexion (the motion that should not be effected by EXO-L device), and from combined eversion - dorsal flexion to combined inversion - plantar flexion (the motion that is expected to be restricted by EXO-L device).

Secondary

MeasureTime frame
The secundary outcomes are the AOFAS patient reported outcome measure, 4-points scale for pain, Qualitatively observed gait pattern, functional limitations, activities of daily life, outcomes of the physcial examination of the ankle and position of the ankle and foot.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)