Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

Study Overview
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Brief Summary
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The investigators evaluated the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.

Detailed Description
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Recent studies witnessed how physical exercise may interrupt the devastating decrease of muscle performance in DSP and further experiments are underway to find more exercises for the recovery of motor function impairment. In fact the rehabilitation treatment, that aims at reducing motor disability, preserving gait functions and preventing falling risks, is an interesting therapeutic approach. Literature recommends balance re-training exercises, muscle strengthening, selective stretching and retraining of motor activity. New technologies produced in the recent decades different devices used in strengthening exercises (electromechanical dynamometers), balance recovery (balance platforms) and gait (analyzing treadmills) have visual feedbacks through which the patients may independently monitor accuracy and intensity of their exercises, being therefore strongly motivated and resulting in a high training intensity. These technologies are often used in rehabilitation of different patients, but are rarely employed for DSP. The purpose of this case control study was to examine the effectiveness of the application of analysing treadmill, muscle strengthening and balance training compared to a control intervention in patients with diabetic neuropathy.

Official Title
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Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic

Conditions
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Complications of Diabetes Mellitus, Diabetic Neuropathies

Intervention / Treatment
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* Device: Technological Rehabilitation
* Other: Control Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participants need to have a history of diabetes mellitus type 2, >3 years, (i.e., time from the diagnosis or the beginning of first related signs or symptoms), A diagnosis of Distal Sensorimotor Polyneuropathy associated, Able to walk autonomously, eventually with a aid. Exclusion Criteria: Scoring less than 5 points on the Functional Independence Measure (FIM) (7) locomotion scale, Presenting articular ankyloses, contractures, spasms with important locomotion effects, Presenting bony instability affecting lower limb functionality (unconsolidated fractures, vertebral instability, severe osteoporosis), In presence of attendant clinicopathological conditions contraindicating the rehabilitation treatment (respiratory insufficiency, cardiac/circulatory failure, osteomyelitis, phlebitis and different other conditions), In presence of cutaneous lesions at lower limbs, Scoring less than 22 points on the Mini Mental State Examination (MMSE), Exhibit important behavioural diseases involving aggressivity or psychotic disorders. Had received prior interventions for Distal Sensorimotor Polyneuropathy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technological Rehabilitation<br>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). | Device: Technological Rehabilitation<br>* 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.<br>* Other names: Analyzing treadmill: Biodex Gait Trainer 3.;|
| Active Comparator: Control Rehabilitation<br>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). | Other: Control Rehabilitation<br>* When needed, more than on e therapist are employed in the intervention for safety reasons.<br>* Other names: Manual rehabilitation with the therapist.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day after the treatment | 
| 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. | 1 day after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days after the treatment | 
| 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. | 30 days after the treatment | 
| Change from Baseline of the Functional Independence Measure (FIM) |  | 1 day after the treatment | 
| Change from Baseline of the Tinetti scale |  | 1 day after the treatment | 
| Change from Baseline of the Resting Energy Expenditure (REE) |  | 1 day after the treatment | 
| Change from Baseline of the Respiratory Rate (RR) |  | 1 day after the treatment | 
| Change from Baseline of the Heart Rate (HR) |  | 1 day after the treatment | 
| Change from Baseline of the oxygen saturation (SpO2) |  | 1 day after the treatment | 
| Change from Baseline of the maximal oxygen consumption (VO2 max) |  | 1 day after the treatment | 
| Change from Baseline of the expired minute volume (Ve) |  | 1 day after the treatment | 
| Change from Baseline of the fraction of expired air that is oxygen (FeO2) |  | 1 day after the treatment | 
| Change from Baseline of the Systolic Blood Pressure (SBP) |  | 1 day after the treatment | 
| Change from Baseline of the Diastolic Blood Pressure (DBP) |  | 1 day after the treatment | 
| Change from Baseline of the Glycated Hemoglobin (HbA1c) |  | 1 day after the treatment | 
| Followup change from Baseline of the Functional Independence Measure (FIM) |  | 30 days after the treatment | 
| Followup change from Baseline of the Tinetti scale |  | 30 days after the treatment | 
| Followup change from Baseline of the Resting Energy Expenditure (REE) |  | 30 days after the treatment | 
| Followup change from Baseline of the Respiratory Rate (RR) |  | 30 days after the treatment | 
| Followup change from Baseline of the Heart Rate (HR) |  | 30 days after the treatment | 
| Followup change from Baseline of the oxygen saturation (SpO2) |  | 30 days after the treatment | 
| Followup change from Baseline of the maximal oxygen consumption (VO2 max) |  | 30 days after the treatment | 
| Followup change from Baseline of the expired minute volume (Ve) |  | 30 days after the treatment | 
| Followup change from Baseline of the fraction of expired air that is oxygen (FeO2) |  | 30 days after the treatment | 
| Followup change from Baseline of the Systolic Blood Pressure (SBP) |  | 30 days after the treatment | 
| Followup change from Baseline of the Diastolic Blood Pressure (DBP) |  | 30 days after the treatment | 
| Followup change from Baseline of the Glycated Hemoglobin (HbA1c) |  | 30 days after the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise Therapy