Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Neurocryostimulation for the Treatment of Acute Lateral Ankle Sprain : a Single Blind Randomized Controlled Trial
Brief Summary: The objective of this exploratory randomized control trial is to compare, in participants with acute lateral ankle sprain (LAS) , the reduction of symptoms and functional limitations between two groups of subjects who undergo a conventional rehabilitation program with (experimental group) or without CRYOFOS (comparison group). The hypothesis is that CRYOFOS will lead to a faster reduction of symptoms and functional limitations, and a faster return to daily living activities.Thirty-six participants of 18 years of age and older with acute LAS (sustained a LAS three days or less before the first evaluation session) will be recruited and randomly assigned to either a group receiving conventional rehabilitation program with the addition of CRYOFOS (experimental group; n=18), or to a group only receiving the conventional rehabilitation program (comparison group; n=18). This single-blind (evaluator), parallel-group RCT will include five evaluation sessions over 6 weeks (baseline, day 7, week 2, week 4 and week 6) and 8 treatment sessions (1st and 2nd weeks: 3 sessions/week; 3rd and 4th weeks: 1 session/week) during a 4-week period. The primary outcome will be the functional limitations, evaluated using the Lower Extremity Functional Scale (LEFS).