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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