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 |