While the CHMP adopted a negative opinion of the extension, PTC was informed by EMA representatives that the European Public Assessment Report, or EPAR, will be updated to clarify that patients who start Translarna while ambulatory are not required to discontinue treatment after loss of ambulation. Translarna is currently indicated for ambulatory Duchenne patients who are over two years of age; the requested extension would have allowed for the inclusion of non-ambulatory patients in the label.
The Functional Ambulation Category (FAC) [15,16] and Hoffer Ambulation Scale [17,18] were used to evaluate functional ambulation levels before and after treatment.
Objective: To determine the effect of two dimensional echocardiography on time of surgery, post-operative ambulation and hospital stay among patients with lower limb fractures.
In their study of the effects of progressive ambulation on heart rate variability following acute MI, SantosHiss and colleagues concluded progressive exercise improved vagal tone and decreased sympathetic and parasympathetic imbalance at rest.
Among ambulatory patients with critical limb ischemia and without a history of prior major amputation, ambulation rates following infrainguinal bypass are 97 percent [2-3] but are only 20 percent among those with such a history [4].
While a number of testing devices advertise that they measure the coefficient of friction on floors, it is important to make sure the device mimics human ambulation. Modern testing devices mimicking human ambulation provide a representative reading of the change in slip resistance between dry and wet floor conditions.
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