Postural Control Clinical Trial
Official title:
The Effect of Whole Body Vibration and Acute Unilateral Unstable Lateral Ankle Sprain - A Biphasic Randomized Controlled Trial -
The aim of this bicentric, biphasic, randomized, controlled study is to compare of the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains over a period of 12 months
Background:
Ankle sprains often result in ankle instability, which is most likely caused by damage to
passive and neurological structures. Whole body vibration (WBV) is a neuromuscular training
method improving those neurologic parameters impaired. The aim of this study is to compare
the current gold standard functional treatment to functional treatment plus WBV in patients
with acute unilateral unstable inversion ankle sprains.
Methods/Design:
60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable
inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled
trial. Patients will be randomized by envelope drawing. All patients will be allowed early
mobilization and pain-depending weight bearing, limited functional immobilization by
orthesis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical
therapy will take place twice a week, 30 minutes per session, for 6 weeks, following a
standardized intervention protocol. During supervised physical therapy, the intervention
group will perform similar exercises on a side-alternating sinusoidal vibration platform as
the control group. Two time dependent primary outcome parameters will be assessed.
Short-term outcome after six weeks will be postural control quantified by the sway index.
Mid-term outcome after one year will be assessed by subjective instability, defined by the
presence of giving-way attacks. Secondary outcome parameters include return to pre-injury
level of activities, residual pain, recurrence, objective instability, energy /
coordination, Foot and Ankle Disability Index and EQ 5D.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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