Technological Rehabilitation of Distal Sensorimotor Polyneuropathy in Diabetic Patients

Not Applicable

Completed

• Conditions: Complications of Diabetes Mellitus; Diabetic Neuropathies
• Interventions: Device: Technological Rehabilitation; Other: Control Rehabilitation

• Registration Number: NCT01926522
• Lead Sponsor: Giovanni Taveggia

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-08-14
• Study First Submitted QC: 2013-08-17
• Study First Posted: 2013-08-21
• Study Start: 2013-09
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-21
• Last Update Posted: 2014-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Technological Rehabilitation	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).
Control Rehabilitation	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).

Primary Outcome Measures

Name	Time	Method
Change from Baseline of 6-minute walk test	1 day after the treatment	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	1 day after the treatment	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.

Secondary Outcome Measures

Name	Time	Method
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
Followup change from Baseline of the Tinetti scale	30 days after the treatment
Followup change from Baseline of 6-minute walk test	30 days after the treatment	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	30 days after the treatment	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)	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 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 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

Trial Locations

Locations (1)

Habilita, Ospedale di Sarnico; 🇮🇹 Sarnico, Bergamo, Italy