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Table 1 Outcomes Measurements

From: Protocol for evaluating the effects of a foot-ankle therapeutic exercise program on daily activity, foot-ankle functionality, and biomechanics in people with diabetic polyneuropathy: a randomized controlled trial

Outcome When will they be evaluated
Baseline 6 weeks 12 weeks 24 weeks Follow-up 1 year
Primary Measures      
 Daily Physical Activity level Number of steps by Accelerometers X   X X X
 Self-selected and fast gait speed Speed in m/s measured by Photoelectric Cells X X X X X
Secondary Measures      
 Foot ulcer incidence Number of new cases of ulcers in 12 months of the study X X X X X
 Ulcer risk classification Classification according to IWGDF X X X X X
 Tactile sensitivity Number of non-sensitive areas measured by 10 g monofilaments X X X X X
 Vibration sensitivity Classification the ability to feel the vibration measured by tuning fork X X X X X
 Tactile sensory threshold Tactile sensitivity threshold between different monofilament thicknesses X X X X X
 Passive ankle range of motion Ankle angle measured by a digital electrogoniometer X X X X X
 DPN Symptoms Score of Michigan Neuropathy Screening Instrument (MNSI) X X X X X
 Quality of life Score of EQ-5D questionnaire X X X X X
 Foot health and functionality Scores of FHSQ-BR questionnaire X X X X X
 Foot muscles strength Maximum force obtained on EMED pressure platform X X X X X
 Plantar pressure Peak pressure obtained on EMED pressure platform X   X   
 Foot-ankle kinematics and kinetics during gait Three-dimensional motion capture and a force platform X   X