Effect of Customized Software for Foot-related Exercises (SOPeD) for Prevention and Treatment in People With Diabetic Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Diabetic Neuropathies
Study type: Interventional

Summary: 
      The main objective of this trial is to investigate the effect of a customized foot-related
      exercises software (SOPeD) in diabetic neuropathy status, functional outcomes and gait
      biomechanics in people with diabetic neuropathy.
    

Detailed description: 
      A randomized controlled trial will be performed with 62 patients with diabetic neuropathy.
      The participants will be randomly assigned into either a control group (recommended foot care
      by international consensus with no foot exercises) or an intervention group that will perform
      exercises at home, three times a week, through the SOPeD (Diabetic Foot Guidance System)
      software for 12-weeks. The exercise program is customized during the performance by a
      perceived effort scale reported by the participant.

      The subjects will be evaluated in 3 different times to access the effect of the intervention:
      baseline and 12 weeks, for all outcomes; and 24 weeks, for follow-up reasons for all
      outcomes. The following outcomes will be assessed in all times: (1) diabetic neuropathy
      symptoms and signs by Michigan Neuropathy Screening Instrument, (2) fuzzy score of the
      neuropathy severity, (3) foot-ankle kinematics during gait (infrared cameras) (4) foot-ankle
      joint moment during gait (infrared cameras and force plate), (5) plantar pressure
      distribution during gait, (6) tactile (monofilaments), (7) vibration sensitivity (tuning
      fork), (8) foot health and functionality by the Foot Health Status Questionnaire, (9) Foot
      isometric strength (pressure plate measurement), (10) functional balance reach test.

      The hypothesis of this study is that the intervention will increase the perception of the
      tactile and vibratory sensitivity of the foot, reduce the symptoms of diabetic neuropathy,
      increase the strength of the foot muscles, increase the functional balance score, decrease
      the severity of the diabetic neuropathy (fuzzy score), decrease the number of neuropathy
      symptoms, promote a more physiological foot rollover with a redistribution of plantar
      pressure during gait, as well as increase foot-ankle mobility after 12-weeks of intervention.
      There will be also beneficial biomechanical changes during gait, such as: (1) increase in the
      ankle extensor moment and ankle concentric power in the propulsion phase and (3) increase in
      the ankle flexor moment and ankle eccentric power in the load phase.
    

Intervention name(s): Physical therapy by foot-ankle segmental and functional exercises
Intervention type(s): Other
Intervention description(s): The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise therapy; diabetic foot; preventive care; foot-related exercises; self-management; software; musculoskeletal function