Ankle Injuries Clinical Trial
Official title:
The Role of the Peroneus Brevis and Peroneus Longus in Patients With Chronic Ankle Instability and the Effect of an Exercise Intervention
This study aims to investigate the activity patterns of the peroneal muscle group, in
individuals with a history of chronic ankle instability (CAI) of the ankle injuries compared
with individuals without ankle problems. The study also aims to determine the effect of a
targeted exercise programme on this muscle group in patients with CAI.
Research on this topic may provide important insight on the roles of these muscles in
chronic ankle instability and investigate whether specific strengthening programmes are
effective in this complex patient category.
The purpose of this study is to evaluate the role of the peroneus brevis (PB) and peroneus
longus (PL) muscles in patients with chronic ankle instability and to determine whether an
eccentric- concentric focused training intervention has an effect on these muscles.
Volunteers will be recruited from Orthopaedic Clinics and the Musculoskeletal Assessment
Clinics in St. Vincent's University Hospital. Posters and information leaflets will be
supplied to areas where volunteers are being sought. A study information sheet will be given
to the patient and written consent will be obtained prior to commencing the investigative
study.
Inclusion Criteria The selection criteria for chronic ankle instability (CAI) patients will
be based on the position statement of the International Ankle Consortium (Gribble et al.
2013).
- A history of at least 1 significant ankle sprain
- A history of the previously injured ankle joint "giving way", and/or recurrent sprain,
and/or "feelings of instability". Self-reported ankle instability confirmed with
validated ankle instability-specific questionnaire: The Cumberland Ankle Instability
Tool (CAIT). CAIT is a simple, valid, and reliable tool to measure severity of
functional ankle instability.
- A general self-reported foot and ankle function questionnaire is also completed. The
Foot and Ankle Ability Measure (FAAM): The FAAM is a reliable, responsive, and valid
measure of physical function for individuals with a broad range of musculoskeletal
disorders of the lower leg, foot, and ankle.
Exclusion Criteria
- Acute injury to musculoskeletal structures of other joints of the lower extremity in
the previous 3 months that impacted joint integrity and function (ie, sprains,
fractures), resulting in at least 1 interrupted day of desired physical activity
- Any Neurological problem that would affect muscle function of the lower limb
- Pregnant Women
- Participants under 18 and over 65 Controls
- Healthy Volunteers (Control) will be age and sex matched to their CAI variants
- Will have no previous history of significant ankle sprain, which interrupted desired
physical activity.
CAI patients will then be referred on for two radiological examinations in St. Vincent's
Hospital to aid diagnosis:
1. A diagnostic ultrasound will be performed by Dr. Eric Heffernan to look at peroneal
tendon pathology and ligament character (thickening and continuity).
2. Stress Fluoroscopy (Anterior Drawer and Talar Tilt) will be performed by Professor
Robert Flavin to assess for biplanar instability and to out rule subtalar instability.
Both participants with CAI and participants without ankle instability will undergo Surface
electromyography (S-EMG) assessment of the PL, PB and Tibialis Anterior (TA) in both static
and dynamic conditions in the University College Dublin School of Public Health,
Physiotherapy & Population science (SPHPPS) motion analysis laboratory (This assessment
process will initially be piloted on a healthy volunteer) Muscle onset will be determined
and S-EMG will also normalized to Max Voluntary Contraction (MVC) determining the magnitude
of activation, during Single leg Stance, wobble-board standing, walking, calf-raise
exercise, tip-toe walking, jogging and a jump-landing task.
Kinematic variables (degrees of movement and speed) will also be re-coded using CODA motion
capture system during the movement tasks.
The participants will be performing the functional tests on a force platform to allow for
assessment of kinetic variables measuring ground reaction force and measures of postural
control.
Following S-EMG testing the CAI subjects will commence a six-week eccentric-concentric
focused exercise programme.
The exercise intervention will consist of an individual home-based progressive
eccentric-concentric strengthening programme. Patients will be reviewed every two weeks
during their rehabilitation; exercises will be progressed accordingly by their
physiotherapist.
Patients will be supplied with exercise diaries to assist with adherence to the exercise
protocol.
At the end of the six-week programme they will undergo repeat S-EMG testing and complete the
self-reported ankle questionnaires used at pre-test phase.
If using a power level of 80% and 5% significance, a sample size of 13 participants for each
study group would be required for this study. To allow for a 23% dropout rate we will aim to
recruit 16 patients to each group.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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