Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

实验性的：Technological Rehabilitation

Experimental group receives a treatment of: 20 minutes of analyzing treadmill with feedback focused on symmetry and length of stride; 20 minutes of isokinetic dynamometric muscle strengthening of flexor and extensor muscles of tibiotarsal joint; 20 minutes of balance retraining on dynamic balance platform. Each patient receives 20 sessions over a period of 4 weeks (5 sessions per week).

设备：Technological Rehabilitation

The length of stride of reference used during the exercise is personalized and depends on the height of patients. Each patient carries out the feedback for 20 minutes with the aim of generating the most symmetric and regular gait.

Patients, with the dynamometer, work on strengthening of flexor and extensor muscles with ankle speeds at 90°/sec and 120°/sec. The strengthening technique was performed twice for 10 minutes each time with a 1 minute rest between sets.

The session ends with a 20-minute feedback on dynamic balance platform by carrying out exercises in which they need to reach randomly appearing targets. Subjects begin with 12 minutes the first 4 sessions, progress to 16 minutes the next 2 sessions, then 18' (2 sessions), and finally 20', if able, during the last 4 sessions.

其他名称：

• Dynamometric isokinetic device: Biodex System 4,
• Balance device: Biodex Balance System SD,
• Analyzing treadmill: Biodex Gait Trainer 3.

有源比较器：Control Rehabilitation

Control group receives the same number of treatment sessions of same duration as those in the experimental group: activities targeted to improve the endurance (instead of analyzing treadmill ), manual exercises of lower limb muscle strengthening, stretching exercises (instead of dynamometer), gait retraining on the floor for 20 minutes and static and dynamic balance exercises in upright position (instead of dynamic balance platform).

其他：Control Rehabilitation

When needed, more than on e therapist are employed in the intervention for safety reasons.

其他名称：

• 与治疗师进行手动康复。

Change from Baseline of 6-minute walk test

All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-minute walk test (6MWT) is used to assess endurance.

The 6MWT quantifies functional mobility based on the distance in meters traveled in six minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of diabetic patients and are relevant for an autonomous life. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.

Change from Baseline of 10-metres walk test

All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 10-metres walking test is used to assess gait speed.

The speed is quantified with the 10-metres walk test (TWT) over the ground. The gait speed measurement is performed over the middle 6 meters of the TWT and patients are asked to walk at their comfortable speed. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.

Followup change from Baseline of 6-minute walk test

All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 6-minute walk test (6MWT) is used to assess endurance.

The 6MWT quantifies functional mobility based on the distance in meters traveled in six minutes. This outcome is a measure of endurance and is particularly significant to evaluate the possibility to perform continuative tasks, that are particularly important for the rehabilitation of diabetic patients and are relevant for an autonomous life. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.

Followup change from Baseline of 10-metres walk test

All evaluation procedures are performed by the same examiner who was blinded to the aims of the study and to which group the participants are allocated. The 10-metres walking test is used to assess gait speed.

The speed is quantified with the 10-metres walk test (TWT) over the ground. The gait speed measurement is performed over the middle 6 meters of the TWT and patients are asked to walk at their comfortable speed. Subjects are instructed to walk at a comfortable speed and subjects neurological are able to use assistive devices.

Change from Baseline of the Functional Independence Measure (FIM)

Change from Baseline of the Tinetti scale

Change from Baseline of the Resting Energy Expenditure (REE)

Change from Baseline of the Respiratory Rate (RR)

Change from Baseline of the Heart Rate (HR)

Change from Baseline of the oxygen saturation (SpO2)

Change from Baseline of the maximal oxygen consumption (VO2 max)

Change from Baseline of the expired minute volume (Ve)

Change from Baseline of the fraction of expired air that is oxygen (FeO2)

Change from Baseline of the Systolic Blood Pressure (SBP)

Change from Baseline of the Diastolic Blood Pressure (DBP)

Change from Baseline of the Glycated Hemoglobin (HbA1c)

Followup change from Baseline of the Functional Independence Measure (FIM)

Followup change from Baseline of the Tinetti scale

Followup change from Baseline of the Resting Energy Expenditure (REE)

Followup change from Baseline of the Respiratory Rate (RR)

Followup change from Baseline of the Heart Rate (HR)

Followup change from Baseline of the oxygen saturation (SpO2)

Followup change from Baseline of the maximal oxygen consumption (VO2 max)

Followup change from Baseline of the expired minute volume (Ve)

Followup change from Baseline of the fraction of expired air that is oxygen (FeO2)

Followup change from Baseline of the Systolic Blood Pressure (SBP)

Followup change from Baseline of the Diastolic Blood Pressure (DBP)

Followup change from Baseline of the Glycated Hemoglobin (HbA1c)