The aim of the study is to determine the mechanical effect of EXO-L on the range of motion of the talocrural and subtalar joint in individuals with chronic ankle instability.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Orthotic devices or braces are used to stabilize a chronically instable ankle.
Current braces do protect the ankle from recurrent inversion injuries, but also
limit the function of the ankle thereby affecting sport performance negatively.
EXO-L brace is an alternative device that is specifically developed to be used
in sporting activities. The design is such that dorsal and plantar flexion of
the foot is not constrained while supination (combined inversion - plantar
flexion) of the ankle is constrained.
Study objective
The aim of the study is to determine the mechanical effect of EXO-L on the
range of motion of the talocrural and subtalar joint in individuals with
chronic ankle instability.
Study design
The ranges of motion of the talocrural joint and subtalar joint are measured by
loading the foot with a combination compressive force and moment and
simultaneously imaging the ankle by CT scan. The scan protocol includes first
one high-resolution scan of the ankle in neutral position without the EXO-L
device followed by four low-resolution scans of the ankle in dorsal flexion,
plantar flexion, combined eversion - dorsal flexion, and combined inversion -
plantar flexion without the EXO-L device. The four low resolution scans are
repeated after application of the EXO-L device. The high-resolution scan is
used for segmentation of the tibia, talus and calcaneus. These segmentations
are used for registration to the corresponding bone images in the
low-resolution scan resulting in measures for translation and rotations
relative to the neutral ankle position.
Intervention
The intervetnion is the application of EXO-L. Each subjects is his own control.
The measurements are performed with and without EXO-L.
Study burden and risks
This is an experimental study that involves a low burden to the subjects. The
risk of the radiation from the CT scan is low. The study includes one visit to
the hospital for the experiment. Each subject has to fill out a questionnaire.
There is no direct benefit for the study subjects. Prospective users of the
EXO-L device may benefit of the outcome of the study as the results of the
study may improve the indications for applying the EXO-L device and may lead to
improvement of the design of the device.
Meibergdreef 7
AMSTERDAM 1105 AZ
NL
Meibergdreef 7
AMSTERDAM 1105 AZ
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47339.018.14 |